CompletedInterventionalNot ApplicableLast updated Oct 8, 2020

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

A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population

Overview

ClinicalTrials.gov ID: NCT01844284
Lead Sponsor: Abbott Medical DevicesINDUSTRY
Brief 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.
Study Type

Status

Overall Status: Completed
Start Date: Apr 2013Actual
Primary Completion Date: Jan 2015Actual
Completion Date: Jan 16, 2019Actual

Study Record Dates

First Submitted: Apr 29, 2013
First Submitted that Met QC Criteria: Apr 29, 2013
First Posted: May 1, 2013Estimated
Last Update Submitted that Met QC Criteria: Oct 5, 2020
Last Update Posted: Oct 8, 2020Actual
Last Verified: Jul 2019