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RELINEThe GORE VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Versus Plain Old Balloon Angioplasty (POBA) for the Treatment of Superficial Femoral Artery (SFA) In-Stent Restenosis

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What is being tested

GORE VIABAHN® Endoprosthesis

+ Plain old balloon angioplasty

Device
Who is being recruted

Cardiovascular Diseases

+ Vascular Diseases

+ Peripheral Vascular Diseases

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: May 2010
See protocol details

Summary

Principal SponsorFlanders Medical Research Program
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2010

Actual date on which the first participant was enrolled.

This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore \& Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80 Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target lesion revascularization (TLR) within 12 months. In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore \& Associates) will result in greater 12 month primary patency of treated superficial femoral artery in-stent restenotic lesions.

Official TitleThe GORE VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Versus Plain Old Balloon Angioplasty (POBA) for the Treatment of Superficial Femoral Artery (SFA) In-Stent Restenosis
NCT01108861
Principal SponsorFlanders Medical Research Program
Last updated: January 27, 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

Cardiovascular DiseasesVascular DiseasesPeripheral Vascular Diseases

Criteria

22 exclusion criteria prevent from participating
Untreated flow-limiting aortoiliac stenotic disease
Presence of a chronic total occlusion, i.e. a complete occlusion of the failed bare stent that cannot be re-opened with thrombolysis or does not allow easy passage of the guidewire by the physician
Any previous surgery in the target vessel
Severe ipsilateral common/deep femoral disease requiring surgical reintervention
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

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
GORE VIABAHN® Endoprosthesis

Group II

Active Comparator
Plain old balloon angioplasty

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 6 locations

Suspended

Imelda Hospital

Bonheiden, BelgiumOpen Imelda Hospital in Google Maps
Suspended

AZ Sint-Blasius

Dendermonde, Belgium
Suspended

Universitair ziekenhuis antwerpen

Edegem, Belgium
Suspended

Zuid Oost Limburg

Genk, Belgium
Completed6 Study Centers
RELINE | The GORE VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Versus Plain Old Balloon Angioplasty (POBA) for the Treatment of Superficial Femoral Artery (SFA) In-Stent Restenosis | PatLynk