Bifurcation ABSORB OCT Trial

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

Inclusion Criteria:

• Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded).
• Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography.
• Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure,as approved by the appropriate Ethics Committee.

Exclusion Criteria:

• Subject is younger than 18 years of age
• Subject is presenting with a STEMI
• Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
• Subject has known hypersensitivity or contraindication to contrast, aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
• Subject with a limited life expectancy less than one year.
• Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or subject unable to read or write.