Coronary bifurcation lesion Circulatory System Coronary bifurcation lesion
Conditions
Interventions
Complex vs simple PCI
Sponsors
Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Revascularization (TLR) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of binary restenosis >50% (MB) at 6 months 2. Calculated late-luminal loss evaluated by Quantitative Coronary Angiography (QCA) 6 months after PCI 3. Incidence of Target Vessel Revascularization (TVR) and Major Adverse Cardiac Events (MACE) at 6 months | — |
Countries
Germany
Outcome results
None listed