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.
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: \[1\] ReoPro + Sirolimus coated stent, \[2\] ReoPro + bare Stent, \[3\] ReoPro + PTA, \[4\] PTA without ReoPro. Angiographic control will be at 2 and 6 months with block wise randomisation to the treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
University of Tuebingen
Tübingen, Germany
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
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