Cardiovascular Diseases Clinical Trial
Official title:
Bifurcation ABSORB OCT Trial
The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the
efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold
provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive
subjects with and without fenestration towards the side branch.
Patients included in this study will be divided into three different cohorts:
- Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.
- Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.
- Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.
All patients will also have telephone FU at 30 days, 12, 24 and 36 months.
Inclusion of patients in the BISORB OCT trial stopped in November 2016 after safety concerns
of the ABSORB BVS were reported. BISORB OCT included 3 patients, which were all included in
the Academic Medical Center
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