Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
|ClinicalTrials.gov Identifier: NCT00163254|
Recruitment Status : Unknown
Verified September 2006 by University Hospital Tuebingen.
Recruitment status was: Active, not recruiting
First Posted : September 13, 2005
Last Update Posted : September 12, 2006
|Condition or disease||Intervention/treatment||Phase|
|Patients Above 18 Years||Drug: abciximab Device: stent and drug eluting stent||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee|
|Study Start Date :||September 2003|
|Estimated Study Completion Date :||November 2006|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163254
|University of Tuebingen|
|Tuebingen, Germany, 72076|
|Principal Investigator:||Gunnar Tepe, MD||University Hospital Tuebingen|