Interventional therapy of bifurcation lesions: A flow-guided concept to treat side branches in bifurcation lesions - a prospective randomized clinical study (THUEringer BIfurcation Study, THUEBIS-Study)
- Conditions
- Coronary bifurcation lesionCirculatory System
- Registration Number
- ISRCTN22637771
- Lead Sponsor
- Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
1. Male or female patients older than 18 years of age
2. Diagnosis of stable angina or silent ischemia
3. Presence of a de novo, true coronary bifurcation lesion, defined as stenosis >50% in both the Main Branch (MB) and the ostium of the Side Branch (SB). Both branches were required to have a Thrombolysis In Myocardial Infarction (TIMI) flow of at least 2 or 3 as well as a reference vessel size >2.25 mm by visual estimation or a relevant SB which the operator would not have wanted to loosen during the procedure. If two commensurate vessels were present, the main branch was defined as the largest of the two vessels involved.
1. A myocardial infarction in the 24 hours preceding treatment (STEMI and NSTEMI)
2. Stenosis of the left main coronary artery unprotected by a graft
3. Cardiogenic shock
4. Angiographically visible thrombus within the target lesion, restenosis or total occlusion of the target lesion
5. Life expectancy <1 year
6. Suspected intolerance to paclitaxel, aspirin or clopidogrel
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method