Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
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|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|
|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
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): NCT00163254
|University of Tuebingen|
|Tuebingen, Germany, 72076|
|Principal Investigator:||Gunnar Tepe, MD||University Hospital Tuebingen|