Status:
COMPLETED
Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent
Lead Sponsor:
Aesculap AG
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the s...
Eligibility Criteria
Inclusion
- Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
- Presence of one or more coronary artery stenosis \>50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
- One lesion treated with the study device
Exclusion
- Pregnancy
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
- Inability to provide informed consent
- Currently participating in another trial before reaching the primary endpoint
- Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
- Acute or recent myocardial infarction
- left ventricular ejection fraction (LVEF) \< 30 %
- Stroke or transient ischemic attack within 6 months
- Stented segment longer than 23 mm
- Vessel diameter of less than 2,5 mm
- Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT01166711
Start Date
August 1 2010
End Date
July 1 2015
Last Update
January 10 2018
Active Locations (1)
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1
Upper Silesian Heart Center
Katowice, Poland, 40-635