PERIPHERAL VASCULAR

ECLEVAR has extensive experience with Class II and Class III peripheral vascular devices and in offering the most cost-efficient, timely contract research organization (CRO) services for these types of organizations.

Our technical specialists and scientists are adept at developing preclinical testing programs for such products, our Veterinary surgeons are experienced at implanting and evaluating the biocompatibility and functionality of such devices, and our consultants have conducted beneficial gap analyses and audits for many peripheral vascular and neurovascular companies.

SELECT PERIPHERAL VASCULAR CLINICAL EXPERIENCE

Recent Experience :

Peripheral Vascular Stents
- 270 subject/40 center IDE pivotal study (site management, CEC management, and trial execution)
- 269 subject/35 center IDE pivotal study (SFA and PPA) IDE study (site initiation, monitoring, site management, site close-out, DSMB management)
- 270 subject/23 center post market trial (monitoring)
Drug-Coated Balloons
- 230 subject/40 center IDE pivotal study of medical device used post-DCB (site management, monitoring, data management, biostatistics, eTMF)
- 5 ongoing studies (biostatistics including study design, ongoing support, analysis and potential FDA panel; data management)
- Statistical analysis and strategic statistical consulting, including FDA panel support
Embolic Protection Device with Carotid Stent
- 250 subject/35 center IDE pivotal study (full clinical trial support)
- 250 subject/40 center IDE pivotal study (biostatistics, data management, monitoring)
- 100 center registry (data management (EDC), site management, and CEC)
- 150 subject/14 center OUS trial (monitoring)
Endovascular AAA
- 21 subject/6 center Phase I IDE (monitoring)
- 155 subject/25 center Phase II IDE (monitoring)

INTERVENTIONAL CARDIOLOGY EXPERIENCE

Self-expanding stents
- Management of 1,700-patient, 40-site IDE trial
- Management of 1,600-patient, 60 site IDE trial
- Management of 200-patient, 20-site trial of bare metal stent
- Statistical analysis for 1,700-patient IDE stent trial
Coronary saphenous vein graft (SVG)
- IDE for bovine graft used for coronary artery graft, clinical trial
Drug Eluting Stents
- Statistical analysis for 15,000-patient post-market drug eluting stent trial
Drug Coated Balloons
- Statistical analysis of pivotal study, including Advisory Panel support, for DCB
- 400 subject/60 center global IDE pivotal study of DCB below the knee (full clinical trial support)
- Clinical evaluation report (CER) for DCB below the knee

ECLEVAR Associates have supported:

Three pre-approval DES studies
Two label expansion DES studies
Three post-approval DES studies, including large international registries

Peripheral Vascular Experience

Embolic protection device with carotid stent
- Full clinical trial support for IDE pivotal 35 sites, 250 patients
- Biostatistics, Data management (EDC), Clinical monitoring (40 sites, 250 patients)
- Data management (EDC), site management, and CEC for 100 center registry

Peripheral Vascular Stent IDE Studies

270 subject/40-center peripheral vascular stent IDE study (site management, CEC management, and trial execution)
270 subject/35-center peripheral vascular stent IDE study (monitoring)

Endovascular AAA IDE study

Monitoring (approximately 3 years); 6 sites; 21 subjects (Phase I IDE) and 25 sites; 155 subjects (Phase II IDE)
280 subject/14 center post market registry in France (project management, monitoring and data management)

Are ECLEVAR‘s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

NEWS
EVENTS
WHITE PAPERS

EU ISSUES Q&A DOCUMENT TO PROVIDE FURTHER ANALYSIS OF POTENTIAL NO-DEAL BREXIT

Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,”Read More..

JOIN ECLEVAR AT MEDTEC JAPAN

ECLEVAR invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 April.