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AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population

NCT01844284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-10-08

Study results available
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Summary

Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.

Conditions

Interventions

DEVICE

XIENCE PRIME®/XIENCE Xpedition™

Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

DEVICE

Absorb™ BVS

Subjects receiving Absorb™ BVS

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Takeshi Kimura, MD · Kyoto University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-01-31
Completion
2019-01-16

Countries

  • Japan

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 NCT01844284 on ClinicalTrials.gov