coronary atherosclerosis coronay bifurcation lesion
Conditions
Interventions
Group A:
In the drug eluting stent (DES) group, a similar approach ,as used in the
Nordic bifurcation study, is requested. The SES "Cypher Select" (Cordis/Johnson
& Johnson, Miami Lakes, Fla) is use
(2) side branch dilatation if there is TIMI (Thrombolysis In Myocardial
Infarction )flow
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years or older -stable or unstable angina pectoris or silent ischemia -and a de novo coronary bifurcation lesion. (A bifurcation lesion is defined according to Louvard/Lefevre (15) et al. and can be located in the anterior descending artery and a diagonal, the circumflex artery and an obtuse marginal or the right coronary artery and posterior descending artery/posterolateral artery). -The diameter of the main vessel and of the side branch should be 2.5 mm and 2.0 mm, respectively, by visual estimate.
Exclusion criteria
Exclusion criteria: - ST-segment elevation acute myocardial infarction within 24 hours, - life expectancy 200 µmol/L, - allergy to any of the drugs used (aspirin, clopidogrel, sirolimus, and paclitaxel) - left main bifurcation lesion. - Inability to cover the lesion in the main vessel with one stent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of the study is the clinical combined end point (MACE) of cardiac death, myocardial infarction, and stent thrombosis or target-vessel revascularization by PCI or coronary artery bypass surgery after 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints (if applicable) (1) the individual end points of death from any cause, cardiac death, myocardial infarction, target-lesion revascularization, and target-vessel revascularization; (2) procedure-related biomarker increase ( 3 times the upper limit of normal of CK-MB mass, troponin-T, or troponin-I); and (3) the combined angiographic end point of significant restenosis (>50% diameter stenosis) of the main vessel and/or occlusion of the side branch. (4) The number of major bleedings according to the TIMI -and/or GUSTO criteria. | — |
Countries
Netherlands
Outcome results
None listed