Trials / Completed
CompletedNCT01220245
SuperB Trial: SUrgical Versus PERcutaneous Bypass
Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Rijnstate Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Heparin-bonded ePTFE endoluminal fem-pop bypass | Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass |
| PROCEDURE | Surgical femoro-popliteal bypass. | Surgical femoro-popliteal bypass. |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2020-08-01
- Completion
- 2020-08-01
- First posted
- 2010-10-13
- Last updated
- 2021-01-25
Locations
6 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01220245. Inclusion in this directory is not an endorsement.