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Bifurcation ABSORB OCT Trial

NCT02928198 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-01-17

No results posted yet for this study

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

Interventions

DEVICE

ABSORB BVS

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • J.J. Wykrzykowska

    lead OTHER

Principal Investigators

  • Joanna J Wykrzykowska, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02928198 on ClinicalTrials.gov