Completed

VMI-CFAVMI-CFA Study: Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery

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What is being tested

Supera Peripheral Stent System

Device
Who is being recruted

Arterial Occlusive Diseases+4

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2016
See protocol details

Summary

Principal SponsorID3 Medical
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 25, 2016

Actual date on which the first participant was enrolled.

The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.

Official TitleVMI-CFA Study: Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
NCT02804113
Principal SponsorID3 Medical
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesPeripheral Vascular DiseasesAtherosclerosisPeripheral Arterial Disease

Criteria

11 inclusion criteria required to participate
Patient presenting a score from 2 to 4 following Rutherford classification
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient is >18 years old
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Show More Criteria
17 exclusion criteria prevent from participating
Presence of another stent in the target vessel that was placed during a previous procedure
Previous open surgery in the same limb
Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
Patients who exhibit persistent acute intraluminal thrombus at the target lesion site.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

ZNA Stuivenberg

Antwerp, BelgiumOpen ZNA Stuivenberg in Google Maps
Suspended

OLV Ziekenhuis Aalst

Aalst, Belgium
Suspended

AZ Sint-Blasius

Dendermonde, Belgium
Suspended

Imelda Hospital

Bonheiden, Belgium
Completed7 Study Centers