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Vascular · Endovascular · Angiography Core Lab

The vascular medical device CRO with core lab access.

Strong capability for vascular clinical studies with access to a specialized vascular research site and angiography core laboratory, a clinical research site active in over 30 cardiovascular trials, and EU MDR evidence designed the way Notified Bodies expect to read it.

Eclevar is a specialist medical device CRO in Europe, supporting sponsors from first-in-human through CER and PMCF under the EU MDR.

Discuss your vascular clinical program See the vascular case study
  • Vascular and endovascular specializationEndovascular surgery and clinical investigation in house
  • Angiography core lab accessAngiography, intravascular, echocardiography, coronary physiology
  • Cardiovascular clinical leadershipFormer TÜV SÜD lead cardiovascular reviewer
  • EU MDR clinical evidenceClinical investigations, PMCF and clinical evaluation
  • Stents & stent-grafts
  • Catheters & guidewires
  • Endovascular prosthesis
  • DSMB & CEC
  • Angiography core lab
Specialist vascular capability

Specialized capability for vascular clinical studies.

Eclevar MedTech is positioned with access to a specialized vascular research site and angiography core laboratory, and a clinical research site actively participating in over 30 cardiovascular trials. Our specialist team works with in-house clinicians in endovascular surgery and clinical investigation.

What is a vascular medical device?

A vascular medical device is used during open surgery and endovascular techniques to control, diagnose, monitor or correct disease or injury. It encompasses cardiovascular, peripheral vascular and neurovascular anatomy.

Experienced vascular team

Our team specializes in implants, endovascular prosthesis and stents intended for use in arteries and veins, collaborating with in-house clinicians specialized in endovascular surgery and clinical investigation.

Reviewer examining angiography and vascular imaging data on screen for a clinical trial core lab
Device coverage

Examples of products we cover.

Interventional and endovascular delivery

  • Cardiac ablation catheters
  • Intravascular imaging catheters
  • Balloon catheters & guidewires
  • Vascular closure devices

Implants, stents and grafts

  • Drug-eluting & bare metal stents
  • Stent-grafts (textile)
  • Vascular grafts (ePTFE)
  • Transcatheter & surgical valves

Aortic, neurovascular and specialty

  • AAA treatment devices
  • Neurovascular flow diverters
  • Embolic & IVC filters
  • Renal artery denervation tools
One partner, from strategy to evidence
  1. 01Clinical strategy
  2. 02Feasibility & sites
  3. 03Study start-up
  4. 04Clinical operations & monitoring
  5. 05Data, imaging & core lab
  6. 06DSMB & CEC
  7. 07Clinical evidence
Cardiovascular leadership

A recognized European cardiovascular team

Portrait of Dr Mark Da Costa, Chief Operating Officer and Head of Cardiovascular at Eclevar MedTech

Dr Mark Da Costa

Chief Operating Officer & Head of Cardiovascular

25+ years in cardiac surgery and cardiovascular device evaluation

  • Cardiac surgeon, and former TÜV SÜD lead cardiovascular reviewer
  • Reviewer experience across 400+ cardiovascular devices
  • Leads Eclevar's TAVI, structural heart and high-risk device programs

Relevance to a vascular program: he has read cardiovascular clinical evidence from the Notified Body side, so gaps surface while the study can still address them.

Mark Da Costa on LinkedIn
Portrait of Sebastien Meier Piantanida, Chief Data Officer at Eclevar MedTech

Sébastien Meier Piantanida

Chief Data Officer · Biometrics & Data Systems

  • 30 years in clinical data management, EDC and biometrics
  • Expertise in CDISC, CDASH, SDTM and ADaM
  • Oversees validated data flows between sites, the core lab and statistics

Relevance: core lab imaging and site data arrive as one analyzable data set.

Sébastien Meier Piantanida on LinkedIn
Portrait of Mathilde Renier, Senior Clinical Data Manager for cardiovascular studies at Eclevar MedTech

Mathilde Renier

Senior Clinical Data Manager · Cardiovascular

  • 10+ years in cardiovascular clinical data management
  • Coordinates imaging and endpoint data from the core lab to analysis
  • Supports VARC-3-aligned data collection, review and traceability

Relevance: endpoint data is structured for review from the first database build.

Mathilde Renier on LinkedIn
Portrait of Charline Petitdemange, Lead Clinical Project Manager for cardiovascular programs at Eclevar MedTech

Charline Petitdemange

Lead Clinical Project Manager · Cardiovascular (France & UK)

  • 10+ years in clinical research and medical device studies
  • Leads cardiovascular investigations and PMCF studies from start-up to close-out
  • Manages site coordination, monitoring, timelines and cross-functional teams

Relevance: one point of accountability for delivery across French and UK sites.

Charline Petitdemange on LinkedIn

Former positions are stated for biographical context only. Eclevar is independent and is not endorsed by the organizations named. Notified Body experience is professional background, not a medical qualification.

Clinical oversight

DSMB & CEC services.

Ensuring participant safety and data integrity through periodic risk-benefit evaluation and independent event adjudication.

DSMB setup & activities

  • Charter & adjudication form development
  • Expert member selection
  • Participant dossier development
  • Meeting coordination & results communication

Clinical Events Committee (CEC)

  • Identification of adjudicable events
  • Clinical document retrieval
  • Rigorous meeting minutes & documentation
  • Direct liaison with data management
Cardiovascular CoreLab

Reproducible imaging for evidence-based outcomes.

Cardiovascular medicine is increasingly dictated by evidence-based guidelines. Our Center for Advanced Imaging assesses the imaging component of trials to ensure it is reproducible and yields the best outcomes, in collaboration with the CORRIB core lab.

How imaging becomes clinical evidence in a vascular study

  1. 01Clinical sitesTrained on the imaging protocol
  2. 02Imaging acquisitionOne standard across every site
  3. 03Core lab reviewIndependent reading, blinded to the site
  4. 04Adjudicated endpointsCEC adjudication, DSMB safety review
  5. 05Clinical evidenceEndpoint data for evaluation and PMCF
The imaging chain in a vascular study, from acquisition at the site to the endpoint data used in the clinical evaluation. The figure describes a workflow and represents no study result.
  • Angiography core lab
  • Intravascular & echocardiography lab
  • Coronary physiology core lab
  • 4D echocardiography (LV size & EF)
Case study

Vascular patch, Class III.

Class III vascular patch Vascular · Real world evidence PMCF study · Multicenter, Europe PMCF study

Intended safety and performance claims that existing evidence did not yet support.

The evidence challenge

Intended claims on safety and performance were not sufficiently supported by existing evidence. A comprehensive PMCF study was required under EU MDR Chapter VI and ISO 14155:2026.

Study objectives

  • Confirm safety in carotid and femoral locations
  • Identify emergent risks based on factual evidence
  • Ensure continued acceptability of the benefit-risk ratio

Study design

Multicenter real world evidence study. 250 to 300 subjects evaluated across 8 sites, with data retrieved from medical charts from baseline to 3 years post-surgery.

Eclevar's role

Eclevar designed the study, coordinated the participating sites and managed data collection, monitoring and reporting for the sponsor.

250 to 300subjects evaluated
8participating sites
3 yearspost-surgery data window
Class IIIdevice classification

Evidence outcome

  • Accepted by the Notified Body
  • Representative patient population
  • Validated long-term durability

A program-specific outcome, described with the sponsor's permission. It is specific to this device, indication and study population, and implies no regulatory outcome for any other program.

Planning a vascular clinical investigation? Discuss the evidence strategy with our team before the protocol is fixed, when design choices still cost nothing to change.

Discuss your evidence strategy
Why Eclevar MedTech

Why partner with Eclevar.

01

Global market access

Support clinical trials in the EU, UK, Australia and Japan with one partner.

For you: one project team across regions, instead of separate vendors.

02

CoreLab integration

Imaging endpoints read in collaboration with the CORRIB core lab.

For you: imaging and study data move through one evidence workflow.

03

Product expertise

Clinical project managers specialized in complex vascular trials.

For you: vascular endpoints understood by the people running the study.

04

In-house clinical team

Dedicated registered nurses and technical specialists for research.

For you: site-facing work stays with Eclevar, not a subcontractor.

05

DSMB expertise

A track record in Data Safety Monitoring Board management.

For you: independent safety oversight set up and run for you.

06

Next-gen technology

Proprietary EDC, ePRO and e-consent technology designed to support vascular data capture.

For you: site, imaging and participant data in one connected environment.

Frameworks we work to

  • EU MDR 2017/745
  • ISO 14155:2026
  • ISO 13485
  • 21 CFR Part 11
  • GDPR
Eclevar MedTech receiving the Platinum Award at the xShare and EUCROF Open Call Awards for Clinical Research in Amsterdam
Platinum Award 2026

Eclevar MedTech and Milo took the Platinum Award at xShare & EUCROF.

Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam. The award recognizes data innovation.

Co-funded by the European Union · Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026

See the official announcement Press coverage
Social proof

Trusted by vascular and cardiovascular leaders.

Manufacturers choose Eclevar as their specialist CRO for vascular and endovascular programs. Read all client success stories.

Across the wider Eclevar client portfolio

Official content

Our content, signed Eclevar.

Cover of the whitepaper written by Notified Body BSI and Eclevar on clinical evidence under the EU MDR
Whitepaper · BSI x Eclevar

A BSI and Eclevar whitepaper on the EU MDR.

Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any high risk device program, vascular and endovascular devices included.

Read the whitepaper

Still from the RegenLab video testimonial on the PMCF program managed by Eclevar
Testimonial · RegenLab

A client's live testimonial on Eclevar's capability to run complex trials.

Eclevar manages RegenLab's PMCF program on chronic wound devices: a randomized study of 160 participants across 14 sites in 5 EU countries.

« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »Antoine Turzi, CEO, RegenLab

Watch the testimonial

Radiology workstation used for medical device imaging evidence review under the EU MDR
Upcoming · TÜV SÜD x Eclevar

Breakthrough Device Technology under the EU MDR.

A Notified Body perspective on the designation, evidence generation and conformity assessment of breakthrough devices under the EU MDR. Joint publication to come, with Dr Nikhil Khadabadi, CMO, Eclevar MedTech.

Coming soon

Questions

Questions vascular sponsors ask us.

What is a vascular medical device?

A vascular medical device is used during open surgery and endovascular techniques to control, diagnose, monitor or correct disease or injury. It spans cardiovascular, peripheral vascular and neurovascular anatomy, and includes stents, grafts, catheters, closure devices and implants for arteries and veins.

Why choose a specialist vascular device CRO in Europe?

Vascular programs under EU MDR need imaging core lab capability, endovascular clinical expertise, robust DSMB and CEC governance and Notified Body insight. Eclevar combines access to an angiography core lab with a clinical site active in over 30 cardiovascular trials and a former Notified Body reviewer on the leadership team.

What core lab capabilities does Eclevar offer for vascular trials?

Angiography core lab, intravascular and echocardiography lab, coronary physiology core lab and 4D echocardiography for left ventricular size and ejection fraction, delivered so the imaging component of a trial is reproducible and yields the best outcomes.

Does Eclevar provide DSMB and Clinical Events Committee services?

Yes. Eclevar sets up Data Safety Monitoring Boards (charter and adjudication forms, expert member selection, participant dossiers, meeting coordination) and Clinical Events Committees (event identification, clinical document retrieval, rigorous minutes and direct liaison with data management).

Which vascular devices does Eclevar cover?

Cardiac ablation and intravascular imaging catheters, AAA treatment devices, neurovascular flow diverters, drug-eluting and bare metal stents, embolic and IVC filters, balloon catheters and guidewires, transcatheter and surgical valves, vascular closure devices, ePTFE grafts and textile stent-grafts.

Can Eclevar run a PMCF or real world evidence study for a Class III vascular device?

Yes. Eclevar has delivered a multicenter real world evidence PMCF study for a Class III vascular patch, 250 to 300 subjects across 8 sites with data from baseline to 3 years post-surgery, under EU MDR Chapter VI and ISO 14155:2026.

Vascular program inquiry

Ready to advance your vascular device program?

Send the device description, the intended claims and the clinical evaluation gap. Our vascular team comes back with the evidence model that answers it and what it takes to run it.

Discuss your vascular clinical program Read client success stories

Reforming Clinical Evaluation of Medical Devices in Europe