Bifurcation ABSORB OCT Trial

NCT ID: NCT02928198

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fenestration

Fenestration of the Absorb Biovascular Scaffold towards the side-branch

Group Type: ACTIVE_COMPARATOR

ABSORB BVS

Intervention Type: DEVICE

No Fenestration

No fenestration of the Absorb Biovascular Scaffold towards the side-branch

Group Type: ACTIVE_COMPARATOR

ABSORB BVS

Intervention Type: DEVICE

Interventions

ABSORB BVS

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

J.J. Wykrzykowska

OTHER

Sponsor Role: lead

Responsible Party

J.J. Wykrzykowska

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joanna J Wykrzykowska, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Academic Medical Center

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

NL50172.018.14

Identifier Type: -

Identifier Source: org_study_id