Drug eluting BALLoon angioplasty to prime bifuRcation lesiOns for stenting: a prOspective randoMized trial

Withdrawn

Conditions: coronary atherosclerosis
coronay bifurcation lesion
10011082

Registration Number: NL-OMON33521

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 200

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

- ST-segment elevation acute myocardial infarction within 24 hours,
- life expectancy <1 year,
- S-creatinine > 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point of the study is the clinical combined end point (MACE) of<br /><br>cardiac death, myocardial infarction, and stent thrombosis or target-vessel<br /><br>revascularization by PCI or coronary artery bypass surgery after 12 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints (if applicable)<br /><br>(1) the individual end points of death from any cause, cardiac death,<br /><br>myocardial infarction, target-lesion revascularization, and target-vessel<br /><br>revascularization;<br /><br>(2) procedure-related biomarker increase ( 3 times the upper limit of normal of<br /><br>CK-MB mass, troponin-T, or troponin-I); and<br /><br>(3) the combined angiographic end point of significant restenosis (>50%<br /><br>diameter stenosis) of the main vessel and/or occlusion of the side branch.<br /><br>(4) The number of major bleedings according to the TIMI -and/or GUSTO criteria.</p><br>