The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions. (DURAVEST)
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|ClinicalTrials.gov Identifier: NCT00289055|
Recruitment Status : Terminated (lack of enrollment)
First Posted : February 9, 2006
Last Update Posted : February 24, 2009
|Condition or disease||Intervention/treatment||Phase|
|Arterial Occlusive Diseases||Device: stent Device: angioplasty||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions|
|Study Start Date :||November 2005|
|Primary Completion Date :||June 2008|
|Study Completion Date :||June 2008|
Cordis SMART™ Nitinol Stent
Cordis SMART™ Nitinol Stent
Active Comparator: 2
- Primary patency. [ Time Frame: 12 months ]
- Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography. [ Time Frame: at deployment ]
- Procedural success defined as successful recanalization, without the occurrence of a SAE. [ Time Frame: up to the moment haemostasis has been achieved ]
- Procedural complications, defined as any adverse event [ Time Frame: from start of the procedure up to the moment haemostasis has been achieved ]
- Ankle Brachial Index. [ Time Frame: discharge and 12 months ]
- Treadmill test. [ Time Frame: 12 months ]
- Restenosis measured by Duplex Ultrasound. [ Time Frame: 12 months ]
- Quality of Life assessment. [ Time Frame: baseline, 6, and 12 months post procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289055
|Amsterdam, Netherlands, 1105 AZ|
|Principal Investigator:||Jim Reekers, MD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|