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Neurovascular devices · Stroke and endovascular technologies · Regulation (EU) 2017/745

Neurovascular Medical Device CRO for Stroke and Endovascular Devices

Design and execute neurovascular clinical investigations in Europe with integrated site feasibility, neurointerventional clinical operations, imaging workflows, monitoring, data management, biostatistics and regulatory evidence reporting.

From neurointerventional center selection and imaging endpoints through to database lock, the clinical investigation report and post-market follow-up.

  • Neurovascular devices
  • Stroke
  • Flow diverters
  • Thrombectomy
  • High-risk and Class III where applicable
  • ISO 14155:2026
  • EU MDR
Discuss Your Neurovascular Study Request Neurovascular Site Feasibility
Devices onlyEclevar runs no pharmaceutical portfolio
High-riskClass III evidence methodology, including colleagues who assessed clinical evidence inside a Notified Body before joining Eclevar
One modelClinical operations, imaging coordination, data and biostatistics under one governance model
Why neurovascular is different

Neurovascular studies depend on more than access to interventional centers.

A neurovascular dataset can be complete, monitored and delivered on schedule and still not support the claim it was built for. Four factors can materially affect whether the evidence supports the intended claim.

The evidence is procedure-dependent

What the patient experienced is not only what the device did.

The observed outcome can depend on the device, the procedure performed, the anatomy treated, operator technique, adjunctive treatment, the imaging acquired and the way patients were selected. Where those variables are not named in the clinical investigation plan and captured in structured fields, the analysis may not reliably distinguish the contribution of the device from important procedural, anatomical and treatment-related factors.

What Eclevar does. Specify the procedural variables in the CIP alongside the endpoints, and build the electronic case report form so that access route, technique, adjunctive devices and deployment details are queryable rather than recorded as narrative text.

The endpoints can be imaging-intensive

Where the endpoint is read from an image, the image is study data.

Depending on the device and the claim, a neurovascular program may rely on angiography, CT, MRI, occlusion assessment, device-position assessment, reperfusion analysis or anatomical measurement. Each of those is an acquisition standard, a transfer path and a quality control step before it is an endpoint, and in some programs a centralized interpretation as well.

What Eclevar does. Treat imaging as a workstream with its own charter, site qualification and reconciliation into the database, rather than as material collected at the end.

Acute pathways are operationally demanding

In acute stroke, the study has to fit inside the treatment window.

Where a program enrolls in acute ischemic stroke, recruitment, consent pathways, treatment windows, out-of-hours site readiness and data capture at the point of treatment are demanding in a way that elective neurovascular studies are not. This applies to the acute pathway specifically: an elective aneurysm or intracranial stenting study is planned against a different operational reality and should not inherit acute-stroke site criteria.

What Eclevar does. Separate acute and elective feasibility criteria from the start, and qualify sites against the pathway the protocol actually uses.

The device question outlives the procedure

For an implant, the events that matter can arrive after discharge.

For flow diverters, intracranial stents and other implanted neurovascular technologies, the questions relevant to a clinical evaluation may include patency, occlusion status over time, retreatment, device-related events, reintervention, neurological outcome and long-term safety. Which of these belong in the study depends on the device and the intended claim, and the follow-up structure has to survive site turnover and attrition long enough to answer them.

What Eclevar does. Set the follow-up horizon against the intended claim, device characteristics, expected timing of clinically relevant events and the evidence question rather than against an administrative reporting cycle.

Device families

Clinical evidence for neurovascular technologies across the interventional pathway.

The evidence architecture changes with the technology. These are the areas a clinical investigation plan typically has to resolve for each device family. Device classification is determined from the intended purpose and applicable MDR classification rules. The clinical-investigation pathway and study requirements are assessed separately for the specific program, indication and jurisdictions involved.

Flow diverters
Intracranial aneurysm population and anatomy definition · device deployment and technical success · occlusion assessment and its imaging basis · device-related events · retreatment · long-term imaging follow-up.
Intracranial stents
Technical success definition · patency over the follow-up period · neurological events · reintervention · the follow-up duration the claim calls for.
Mechanical thrombectomy
Procedure metrics and workflow timing · reperfusion assessment · neurological and functional outcomes · safety endpoints · the operational constraints of an acute pathway.
Aspiration, access and delivery systems
Technical performance and navigation · procedure success definition · device deficiency capture · interaction with adjunctive devices used in the same procedure.
Embolization technologies
Intended application and population · deployment · imaging assessment · long-term anatomical and clinical outcome.

Endpoint definitions, thresholds and assessment schedules on this page are described in general terms. Study-specific wording is set with the sponsor and reviewed by the investigators appointed to the program.

Integrated CRO services

One neurovascular CRO from evidence strategy to the final clinical report.

Eight integrated workstreams, one Eclevar governance and coordination point. The scope is agreed per engagement, with Eclevar coordinating the contracted workstreams and qualified partners through one program governance model.

01 Clinical strategy and CIP

Intended indication, study population, eligibility, procedure pathway, primary endpoint, secondary endpoints, follow-up schedule and safety strategy, written as one argument rather than assembled section by section. See also regulatory strategy.

02 Neurointerventional site feasibility

Protocol-relevant patient and procedure volume, investigator experience, experience with the device category, imaging capability, research infrastructure, competing studies and workload, consent pathway and follow-up capability.

03 Regulatory and ethics start-up

Eclevar leads regulatory and ethics start-up, using in-house delivery or qualified local support according to the country, authority and submission pathway, through to site activation and investigator training.

04 Clinical operations

Site initiation, site management, enrollment oversight, deviation management, device accountability and study governance.

05 Clinical monitoring

Procedure documentation, eligibility, primary endpoint source data, device identification and accountability, device deficiencies, imaging completeness, follow-up and protocol compliance, on site and remotely.

06 Imaging workflow and central review coordination

Imaging charter, acquisition standards, site qualification, image transfer, quality control, and coordination of independent central review and endpoint adjudication where required by the protocol or evidence strategy. Eclevar coordinates independent central review; it does not present itself as the reader of record.

07 Data management and EDC

Procedure data, device data, imaging metadata, clinical outcomes, neurological assessments, device deficiencies, follow-up, query management and database lock. See clinical data management and EDC.

08 Biostatistics and medical writing

Statistical analysis plan, endpoint analyses, missing data strategy, sensitivity analyses, prespecified subgroups, the clinical investigation report, and integration into the clinical evaluation report and PMCF documentation.

What you receive

The deliverables a neurovascular engagement produces.

Depending on the contracted scope, an engagement produces some or all of the following. This is the basis of the scoping conversation, not a fixed package.

  • Clinical Investigation Plan
  • Statistical Analysis Plan
  • Neurointerventional feasibility report
  • Site qualification matrix
  • Regulatory and ethics start-up package
  • Imaging charter and imaging workflow, where applicable
  • Monitoring Plan
  • Neurovascular CRF and EDC specification
  • Data Management Plan
  • Endpoint adjudication workflow, where applicable
  • Database lock package
  • Clinical Investigation Report
  • CER and PMCF evidence handover, where included
Discuss Your Neurovascular Study
Neurointerventional site feasibility

The right neurovascular site is the site that can recruit the right patient at the right point in the treatment pathway.

The European centers with the highest procedure volume are not automatically the centers that can carry an investigation. Volume is one input of eight.

Site qualification sequence

Patient flow, then procedure volume, investigator experience, device experience, imaging capability, research infrastructure, competing studies and follow-up capability. Each stage carries the criterion assessed at that step.

Added for acute stroke programs only: emergency pathway, thrombectomy availability out of hours, door-to-imaging workflow and treatment-window constraints. These four are not applied to elective aneurysm or intracranial stenting studies.

European neurointerventional site qualification model. Each center is assessed against the criterion under the step it has to deliver.

What a procedure count will not tell you

  • Protocol-relevant patient and procedure volume over a defined recent assessment period, rather than total procedures. The assessment window is set during feasibility.
  • Whether the investigator’s experience is with the device category under study or with a neighboring one.
  • Whether the imaging the protocol assumes can be acquired to the required standard, by whom, and at what hours.
  • Who is available to consent, follow up and complete data entry alongside routine clinical work.
  • Competing studies, competing clinical workload and available research capacity.

Related: feasibility and site selection.

Request European Neurovascular Site Feasibility
Imaging workflow

Where an endpoint depends on imaging, the imaging workflow starts with the first protocol-defined acquisition.

The reliability of an imaging endpoint depends on the full chain between acquisition at the site and the value that reaches the statistical analysis. Eclevar manages the study-side imaging workflow and coordinates independent central review where required by the protocol or evidence strategy.

Imaging chain of custody

Imaging charter, acquisition standards, site qualification, image transfer, quality control, central review where required, adjudication where required, database integration, statistical analysis.

Steps six and seven are conditional. An independent central core laboratory may be appropriate where the protocol requires it. Not every imaging endpoint requires one.

The imaging chain of custody. The reliability of an imaging endpoint depends on the full chain between acquisition and analysis.

Depending on the device and the claim, the imaging question may be angiographic occlusion, reperfusion, device position, patency, stenosis, anatomical measurement or lesion characteristics. Each calls for a defined acquisition standard, a documented transfer route, a quality control step before review, and reconciliation between the reviewed result and the study record.

An independent central core laboratory may be appropriate where the protocol requires standardized centralized interpretation, endpoint adjudication or independence from the treating investigator. Not every imaging endpoint requires one. Where it is required, Eclevar specifies the imaging charter, qualifies the sites against it, coordinates the independent review and adjudication, and integrates the resulting endpoint back into the clinical database with an audit trail.

Endpoint architecture

Neurovascular endpoints reflect the device, the procedure and the intended clinical claim.

There is no single endpoint set that applies across all neurovascular devices, indications and study objectives.

The endpoint architecture may draw on technical success, procedural success, neurological outcomes, functional outcomes, imaging outcomes, device-related safety, mortality, reintervention, retreatment, patency, occlusion or reperfusion. Which are primary, secondary or descriptive is shaped by six things: the device, the indication, the clinical claim, the study phase, the regulatory objective and the patient population.

An endpoint that is well supported for one neurovascular indication does not transfer automatically to another, to a different device family or to a different follow-up horizon. Endpoint definitions, timepoints and clinically meaningful differences should be justified using the relevant clinical evidence, literature, clinical input and regulatory context as appropriate, and the reasoning documented before enrollment rather than after.

Set out the candidate endpoint definitions, their basis and their consequences for sample size, so that the sponsor and the investigators choose on the record and the rationale is available when it is asked for.

Related: medical device biostatistics.

Data architecture

A neurovascular database has to connect procedure, device, imaging and patient outcome.

Four data domains, one linked patient record. If procedure, device, imaging and clinical outcomes are not linked consistently, it becomes harder to evaluate how those domains relate to one another.

Four data domains, one linked patient record

Procedure: date and time, access route, adjunctive treatment, technical details of the intervention. Device: identification, configuration, deployment, device deficiencies, additional devices used in the same procedure. Imaging: modality, acquisition, transfer status, central review status, adjudicated endpoint where applicable. Clinical: neurological status, functional outcomes, adverse events and device-related events, reintervention, follow-up.

Around those four domains: edit checks, reconciliation, query management, audit trail and database lock. Traceability runs from the source document to the value in the analysis.

Four data domains, one linked patient record.

Around those four domains sit the mechanics that determine how well the dataset holds up under review: edit checks written against the protocol, reconciliation between imaging records and the clinical database, query management, coding where required, a complete audit trail, database lock and traceability from source document to analysis value.

Related: clinical data management and EDC.

Monitoring

Monitor the evidence that determines whether the procedure and the endpoint can be reconstructed.

The monitoring question in a neurovascular investigation is not whether every field is filled. It is whether an independent reader could reconstruct what was done and what happened.

Monitoring focus

  • Eligibility
  • Consent
  • Procedure documentation
  • Device identification
  • Device accountability
  • Primary endpoint source data
  • Imaging completeness
  • Adverse events and device deficiencies
  • Protocol deviations
  • Reintervention
  • Follow-up completeness

Eclevar combines on-site monitoring, remote monitoring and centralized data review, risk-based where it suits the study. ISO 14155:2026 provides the device-specific good clinical practice framework, alongside applicable requirements under Regulation (EU) 2017/745 and national requirements.

Related: on-site and remote clinical monitoring.

Biostatistics

Plan the statistical strategy around the clinical claim and the event structure.

Sample size is the output of a set of assumptions rather than the starting point. The statistical work that shapes a neurovascular investigation sits in the sample size strategy, the primary endpoint definition, the hierarchy between primary and secondary endpoints, time-to-event structures where events accumulate over follow-up, the missing data strategy, prespecified sensitivity and subgroup analyses, and the handling of imaging and adjudicated endpoints. Where applicable, these decisions should be prospectively specified in the protocol and Statistical Analysis Plan rather than introduced after the outcome data are available.

Related: medical device biostatistics services.

Post-market evidence

Plan the evidence pathway beyond the pivotal study.

Evidence pathway

Clinical investigation, long-term follow-up, PMCF, registry or real-world evidence where appropriate, PMCF evaluation, CER update.

Step four is optional. Not every neurovascular device needs a registry.

The evidence pathway beyond the pivotal study. Not every neurovascular device needs a registry.

For an implanted neurovascular device, the questions that arrive after the pivotal study are often about durability: device performance over time, reintervention, retreatment, late neurological events, imaging outcomes and the long-term benefit-risk position. Not every neurovascular device needs a registry. A registry suits questions about long-term performance and real-world use at scale in a population already receiving the therapy, and it generates evidence of a different kind rather than of a lower standard. A dedicated prospective clinical investigation may be more appropriate where a specific clinical benefit claim or hypothesis requires protocol-driven evaluation. Some programs may appropriately combine a dedicated investigation with longer-term registry or real-world evidence.

Related: post-market clinical follow-up, medical device registry CRO, clinical evaluation report.

Delivery record

Relevant high-risk interventional and long-term device evidence experience.

The methodology on this page is built on delivery in high-risk interventional and implantable device programs. Two are closest to what a neurovascular program requires.

Perouse Medical, Vygon Group Implantable vascular devices · post-market evidence · Europe

An observational post-market evidence program across multiple implantable vascular device families

Program

One harmonized evidence model with common safety definitions, comparable clinical performance measures, post-implantation follow-up and a shared data and reporting structure.

Relevance

Portfolio-level harmonization and long-horizon safety and performance follow-up on implanted vascular devices.

Eclevar structured the program architecture and supports delivery.

Meril Life Sciences Class III cardiovascular · TAVI · United Kingdom

A multicenter UK clinical evidence program for a transcatheter valve portfolio

Program

Eclevar has supported a multicenter UK clinical evidence program for a transcatheter valve portfolio, combining clinical study planning, site delivery and cardiovascular evidence generation.

Relevance

High-risk interventional study operations, multicenter site coordination, procedure-dependent evidence, and clinical data and reporting.

No clinical result and no regulatory outcome is attributed to Eclevar.

These programs demonstrate relevant high-risk interventional and long-term device-evidence capability. They are not presented as completed neurovascular clinical investigations.

More client programs: client success stories.

Leadership

Clinical and regulatory leadership for high-risk interventional devices.

Eclevar leads clinical evidence strategy, European study delivery, imaging coordination, biometrics and regulatory integration. Indication-specific neurointerventional expertise is incorporated through appropriately qualified investigators or independent specialists according to program scope.

Dr Mark Da Costa

Chief Operating Officer and Head of Cardiovascular

Clinical evidence architecture for high-risk and Class III devices and interventional device methodology, informed by first-hand experience of assessing clinical evidence inside a Notified Body before joining Eclevar.

Susanne Höfer

Head of Cardiovascular Clinical Operations · DACH

Interventional site qualification, study start-up, monitoring strategy and DACH cardiovascular and interventional delivery.

Charline Petitdemange

Clinical Operations Director

European clinical-study delivery, site management and cross-functional operational governance.

Sébastien Meier Piantanida

Chief Data Officer

Data architecture, EDC and biometrics: electronic data capture design for procedure, device and imaging data, database governance and the analysis-ready dataset.

Pierre-Marie Boutanquoi

Head of Medical Writing

Clinical investigation reports, clinical evaluation reports and PMCF evaluation reports, including responses to questions raised during conformity assessment.

Former positions are stated for biographical context only. Eclevar MedTech is an independent contract research organization. It is not affiliated with, accredited by or endorsed by any Notified Body. Notified Bodies issue certificates; individual reviewers assess technical documentation and clinical evidence.

Full leadership team.

Where neurovascular sits

Neurovascular sits where neurology, interventional practice, imaging and data meet.

Neurovascular is a distinct therapeutic area at the intersection of vascular intervention, neurological outcomes, imaging and device evidence.

Cross-cluster chain

Three inputs feed one program: the vascular practice, providing interventional-device and endovascular operating methodology; the broader neurological practice, providing an adjacent clinical-evidence capability; and imaging, data and biostatistics, held inside the same governance model.

The program chain runs from site feasibility through clinical investigation, imaging, data management, biostatistics and the clinical investigation report to PMCF and CER.

Neurovascular endpoints, investigators and imaging requirements are designed specifically for the indication and device under study.

Eclevar’s vascular practice provides relevant interventional-device and endovascular operating methodology. Eclevar’s broader neurological practice provides an adjacent clinical-evidence capability, while neurovascular endpoints, investigators and imaging requirements are designed specifically for the indication and device under study. Imaging coordination, data management and biostatistics sit inside the same governance model.

Neuromodulation and neuro-implant CRO · Vascular medical device CRO

Why Eclevar

Why sponsors bring a neurovascular program to Eclevar.

  1. Medical devices only

    A methodology written for device evidence rather than adapted to it, with no pharmaceutical portfolio competing for the same delivery team.

  2. High-risk and Class III evidence methodology

    Colleagues who assessed clinical evidence inside a Notified Body before joining Eclevar work on how the evidence is structured, not only on how the study is run.

  3. European interventional site feasibility

    Site qualification against the whole patient pathway, with regulatory and ethics start-up led by Eclevar across the countries in scope.

  4. Clinical operations, imaging, data and biostatistics in one governance model

    The imaging endpoint, the database and the analysis plan are designed against each other rather than handed between disconnected providers.

  5. Evidence that carries into the regulatory documentation

    The clinical investigation report and the CER and PMCF handover are produced by the team that ran the study.

Questions

Questions neurovascular sponsors ask.

What should a neurovascular medical device CRO provide?

Clinical strategy and the clinical investigation plan, neurointerventional site feasibility, regulatory and ethics start-up, clinical operations and monitoring, imaging workflow and central review coordination where required, electronic data capture and data management, biostatistics, medical writing, and integration of the result into the clinical evaluation report and post-market plan. A practical consideration is whether the study-governance model clearly connects the imaging endpoint, the clinical database and the statistical analysis.

How do you select sites for a neurovascular clinical investigation?

From the protocol population rather than from the center’s reputation. The questions are protocol-relevant patient and procedure volume over a defined recent period, whether the investigator’s experience is with the device category under study, whether the imaging the protocol assumes can be acquired to the required standard, who is available to consent and follow up alongside routine care, and what competing studies, clinical workload and research capacity exist at the site. For acute stroke programs, out-of-hours pathway and treatment-window constraints are added.

Can Eclevar support flow diverter clinical trials?

Eclevar can support the CRO workstreams required for a flow-diverter clinical investigation in Europe, including clinical strategy and CIP development, neurointerventional site feasibility, regulatory and ethics start-up, monitoring, imaging-workflow coordination, data management, biostatistics and the clinical investigation report. Published Eclevar experience presented on this page comes from transferable high-risk interventional and implantable vascular programs rather than a completed flow-diverter investigation.

Can Eclevar support thrombectomy device studies?

Eclevar can support the same CRO workstreams for a thrombectomy device investigation, with the operational reality of an acute pathway built into feasibility and start-up rather than discovered at activation: procedure timing, out-of-hours availability, consent pathway and data capture at the point of treatment are assessed before a site is activated. As above, the published experience on this page is transferable rather than a completed thrombectomy program.

When is a core laboratory needed in a neurovascular clinical trial?

An independent central core laboratory may be appropriate where the protocol requires standardized centralized interpretation, endpoint adjudication or independence from the treating investigator. Not every imaging endpoint requires one. Where the protocol does require central review, Eclevar specifies the imaging charter, qualifies the sites, coordinates the independent review and adjudication, and integrates the result into the clinical database.

How are imaging endpoints managed in neurovascular studies?

As a workstream with its own chain of custody: charter, acquisition standards, site qualification, transfer, quality control, review, adjudication where applicable, integration into the database and then analysis. Leaving reconciliation between the review output and the clinical record until database lock can generate avoidable queries and delay endpoint finalization.

How should neurovascular device deficiencies be captured?

Against an event taxonomy defined before first patient in, so that terminology remains consistent across the clinical database, complaint handling and vigilance workflows. Sites are trained against that taxonomy, because reporting conventions differ between centers.

Can Eclevar provide EDC, data management and biostatistics?

Yes. Eclevar builds and runs the electronic data capture covering procedure, device, imaging and clinical domains, with edit checks, query management, reconciliation, audit trail and database lock, and provides the statistical analysis plan, endpoint analyses and the analyses supporting the clinical investigation report.

Can Eclevar run multicountry neurovascular studies in Europe?

Yes. Eclevar supports multicountry European delivery through a combination of in-house clinical operations and qualified local coverage, with central program governance, data, biometrics and medical writing. Country-specific operating models are confirmed during feasibility.

Can a neurovascular clinical investigation feed PMCF and CER updates?

It can if it is designed to. The variables the clinical evaluation will need, the follow-up horizon and the data structure are best decided at protocol stage. Retrofitting a completed investigation to a clinical evaluation that requires different variables can create avoidable rework and may leave evidence gaps that are difficult to resolve retrospectively.

How do you manage long-term follow-up for implanted neurovascular devices?

By planning retention from the outset: a follow-up schedule proportionate to the question, a defined imaging schedule where the endpoint calls for it, site-level responsibility for tracing patients, and, where appropriate to the long-term evidence question, a registry or other post-market evidence model designed to preserve follow-up beyond the primary investigation.

Start the conversation

Planning a neurovascular device clinical investigation?

Bring us the device, the intended indication, the current evidence and the target market. We will review the clinical strategy, the European neurointerventional site landscape, the imaging requirements, the endpoint architecture and the operational pathway with your team.

Request a Neurovascular Study Review Discuss European Site Feasibility

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