Status:
COMPLETED
Rotational Atherectomy Prior to Taxus Stent
Lead Sponsor:
Segeberger Kliniken GmbH
Conditions:
Complex Calcified Coronary Lesions
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an a...
Detailed Description
Calcification is an essential part of all atherosclerotic plaques. Its extent increases with the progression of atherosclerotic disease. Heavily calcified lesions form a particular threat to DES; both...
Eligibility Criteria
Inclusion
- Angiographically proven coronary artery disease
- Angina II-IV° following the Canadian Cardiovascular Society Classification criteria and/or reproducible ischemia in the target area by ECG or scintigraphy
- The patient signing an informed written consent
- From the following angiographic criteria, lesions must fulfil all first degree criteria and at least one second-degree criterion to be eligible for inclusion.
- First degree criteria
- De-novo lesion in a native coronary artery
- Target reference vessel diameter between 2.5 and 4.0 mm by visual estimation
- Luminal diameter reduction of 70-99% by visual estimation
- Moderate to severe calcification of the target lesion (clearly defined)
- Second degree criteria
- Ostial location
- Bifurcational lesions
- Long lesions (≥ 15mm)
Exclusion
- Myocardial infarction within 4 weeks
- Left ventricular ejection fraction \< 30%
- Limited long term prognosis due to other conditions
- Angiographic exclusion criteria:
- Unprotected left main lesions
- Coronary artery bypass graft stenoses
- In-stent restenoses
- Chronic total occlusions
- Target vessel thrombus
- Target vessel dissection
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00380809
Start Date
August 1 2006
End Date
May 1 2011
Last Update
July 26 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795