Vienna Absolute Trial: Balloon Angioplasty Versus Stenting in the Superficial Femoral Artery
Minimal invasive treatment (called "endovascular") of the arteries of the lower limb remains problematic, because recurrent disease ("restenosis") frequently leads to recurrent symptoms. As yet, balloon angioplasty remains the recommended strategy to revascularize the superficial femoral artery (artery of the thigh). We investigated whether the use of a vascular endoprosthesis ("stent") improves patients´ outcome.
Study hypothesis: Primary stenting with self expanding nitinol stents may improve patency after endovascular treatment of superficial femoral artery obstructions compared to balloon angioplasty with optional stenting.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Balloon Angioplasty Versus Stenting With Nitinol Stents in the Superficial Femoral Artery|
- Angiographic restenosis at 6 months
- restenosis by duplex ultrasound at 3,6 and 12 months
- walking distance on the treadmill at 3, 6 and 12 months
- ankle brachial index at 3, 6 and 12 months
- stent fractures at 6 and 12 months
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||August 2005|