Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
Recruitment status was Active, not recruiting
The Below-Study is a randomized, prospective mono-centre trial on the efficacy and safety the adjunctive use of a GP IIb/IIIa antagonist for prevention of early reocclusion in arterial below-the knee interventions.
Patients Above 18 Years
Device: stent and drug eluting stent
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee|
- The primary study objective is to demonstrate the superiority of an adjunctive administration of abciximab and drug eluting stents on the rate of subacute reocclusions at day 60 ± 10.
- The binary restenosis rate (restenosis > 50%) at 6 months
- The rate of mortality, amputation (including toes), repeat target vessel intervention, and healing of ulcers 2 and 6 months from randomization.
- Quality of life assessment 2 and at 6 months compared to baseline
- Change in ankle brachial index (ABI) after the intervention, at 2 and at 6 months.
- Change in Rutherford stages at 2 and at 6 months compared to baseline.
- Hospital days for index hospitalization
- Hospital days for repeat revascularization and amputation at 2 and 6 months
- Safety analysis
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||November 2006|
PTA below the knee is limited due to subacute reocclusions and uncertain long-term results. This study is designed as a feasibility trial, which compares the two new treatment modalities: drug eluting stents and GP IIb/IIIa blockade.
Patients with current ulcers (Rutherford 5, or 6) are randomly assigned to one of the treatment groups:  ReoPro + Sirolimus coated stent,  ReoPro + bare Stent,  ReoPro + PTA,  PTA without ReoPro. Angiographic control will be at 2 and 6 months with block wise randomisation to the treatment groups.