Status:
COMPLETED
The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
B. Braun Melsungen AG
Conditions:
Coronary Artery Disease
Chronic Total Occlusion
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 arte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00670436
Start Date
February 1 2008
End Date
March 1 2014
Last Update
June 10 2014
Active Locations (2)
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1
Klinikum Darmstadt
Darmstadt, Germany, 64283
2
University of Ulm
Ulm, Germany, 89081