The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
Phase 2
Completed
- Conditions
- Chronic Total OcclusionCoronary Artery DiseaseNative Coronary Artery
- Registration Number
- NCT00670436
- Lead Sponsor
- University of Ulm
- Brief Summary
The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- chronic total occlusion
- Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
- occlusion in native coronary artery
- indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
- reference diameter 2.5 mm to 4.0 mm
Exclusion Criteria
- saphenous vein graft
- bifurcation lesion with need to stent main and side branch
- left main occlusion
- de-novo stenosis (no occlusion)
- restenosis
- in-stent restenosis
- contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
- coronary aneurysm at target lesion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Late loss 6 months
- Secondary Outcome Measures
Name Time Method late loss index 6 months percent diameter stenosis 6 months target vessel revascularization 30 days, 6, 12, 24 months major adverse cardiac events 30 days, 6, 12, 24 months binary angiographic restenosis rate 6 months Target lumen revascularization 30 days, 6, 12, 24 months
Trial Locations
- Locations (2)
Klinikum Darmstadt
🇩🇪Darmstadt, Germany
University of Ulm
🇩🇪Ulm, Germany
Klinikum Darmstadt🇩🇪Darmstadt, Germany