Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin-bonded endoluminal fempop bypass | Experimental | Heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass |
|
| Surgical femoro-popliteal bypass | Active Comparator | Surgical femoro-popliteal bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin-bonded ePTFE endoluminal fem-pop bypass | Procedure | Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary (and -assisted) patency | 5 years | |
| Quality of life | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary patency | 5 years | |
| Complications | 5 years | |
| Clinical improvement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MMJP Reijnen, MD, PhD | Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | Netherlands | |||
| Slingeland Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38590283 | Derived | van Walraven LA, Velandia-Sanchez A, Iqbal K, Zeebregts CJ, Holewijn S, Reijnen MMPJ. Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass. J Endovasc Ther. 2026 Feb;33(1):220-226. doi: 10.1177/15266028241245602. Epub 2024 Apr 9. | |
| 21767371 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Surgical femoro-popliteal bypass. | Procedure | Surgical femoro-popliteal bypass. |
|
| 5 years |
| Re-intervention | 5 years |
| Target lesion revascularisation | 5 years |
| Doetinchem |
| Gelderland |
| Netherlands |
| Isala klinieken | Zwolle | Overijssel | Netherlands |
| Nij Smellinghe Hospital | Drachten | Provincie Friesland | Netherlands |
| Antonius Hospital | Sneek | Provincie Friesland | Netherlands |
| University Medical Centre Groningen | Groningen | Netherlands |
| Lensvelt MM, Holewijn S, Fritschy WM, Wikkeling OR, van Walraven LA, Wallis de Vries BM, Zeebregts CJ, Reijnen MM. SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial. Trials. 2011 Jul 18;12:178. doi: 10.1186/1745-6215-12-178. |