NCT02928198

Bifurcation ABSORB OCT Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: J.J. Wykrzykowska · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Myocardial Ischemia
• Ischemia
• Coronary Disease
• Heart Diseases
• Cardiovascular Diseases
• Coronary Bifurcation Lesions
• Arterial Occlusive Lesions
• Infarction
• Myocardial Infarction
• Arteriosclerosis

Interventions

Type	Name	Description
DEVICE	ABSORB BVS

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2016-10-10
• Last updated: 2018-01-17

Locations

1 site across 1 country: Netherlands