The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

Study Overview
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Brief Summary
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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.

Official Title
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The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

Conditions
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Coronary Artery Disease, Chronic Total Occlusion, Native Coronary Artery

Intervention / Treatment
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* Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)
* Device: paclitaxel eluting Taxus stent (Boston Scientific)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A 1<br>paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery | Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)<br>* paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery<br>* Other names: paclitaxel eluting balloon;|
| Active Comparator: A2<br>historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific) | Device: paclitaxel eluting Taxus stent (Boston Scientific)<br>* paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent diameter stenosis |  | 6 months | 
| binary angiographic restenosis rate |  | 6 months | 
| late loss index |  | 6 months | 
| Target lumen revascularization |  | 30 days, 6, 12, 24 months | 
| target vessel revascularization |  | 30 days, 6, 12, 24 months | 
| major adverse cardiac events |  | 30 days, 6, 12, 24 months |