The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions. (DURAVEST)
The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions|
- Primary patency. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography. [ Time Frame: at deployment ] [ Designated as safety issue: No ]
- Procedural success defined as successful recanalization, without the occurrence of a SAE. [ Time Frame: up to the moment haemostasis has been achieved ] [ Designated as safety issue: No ]
- Procedural complications, defined as any adverse event [ Time Frame: from start of the procedure up to the moment haemostasis has been achieved ] [ Designated as safety issue: Yes ]
- Ankle Brachial Index. [ Time Frame: discharge and 12 months ] [ Designated as safety issue: Yes ]
- Treadmill test. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Restenosis measured by Duplex Ultrasound. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Quality of Life assessment. [ Time Frame: baseline, 6, and 12 months post procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Cordis SMART™ Nitinol Stent
Cordis SMART™ Nitinol Stent
Active Comparator: 2
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.
The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.
Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only.
Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.
This study will be conducted at 8 investigational sites in The Netherlands.