NL-OMON33521
Withdrawn
Not Applicable
Drug eluting BALLoon angioplasty to prime bifuRcation lesiOns for stenting: a prOspective randoMized trial - BallRoom
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 200
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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