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ABSORB II Randomized Controlled Trial

NCT01425281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2019-11-13

Study results available
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Summary

Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)

Conditions

Interventions

DEVICE

Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System

XIENCE implantation in the treatment of coronary artery disease.

DEVICE

Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System

ABSORB BVS implantation in the treatment of coronary artery disease.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Patrick W. Serruys, MD, PhD · Erasmus Medical Center

  • Bernard Chevalier, MD · Institut Jacques Cartier (ICPS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-07-31
Completion
2018-05-23

Countries

  • Belgium

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 NCT01425281 on ClinicalTrials.gov