Absorb GT1 Japan PMS

NCT ID: NCT03409731

Last Updated: 2024-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-13

Study Completion Date

2023-02-06

Brief Summary

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The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

Detailed Description

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Conditions

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Ischemic Heart Disease Angina Pectoris Coronary Artery Disease Coronary Artery Occlusion Myocardial Ischemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Absorb GT1 BVS

Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.

Group Type OTHER

ABSORB GT1 BVS

Intervention Type DEVICE

Patients receiving Absorb GT1 BVS

Interventions

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ABSORB GT1 BVS

Patients receiving Absorb GT1 BVS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* General Percutaneous coronary intervention (PCI) population.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Masato Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

Toho University Ohashi Medical Hospital

Locations

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Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, Japan

Site Status

Shin Tokyo Hospital

Matsudo, Chiba, Japan

Site Status

Shin Koga Hospital

Kurume, Fukuoka, Japan

Site Status

Hanaoka Seishu Memorial Cardiovascular Clinic

Sapporo, Hokkaido, Japan

Site Status

Kobe University

Kobe, Hyōgo, Japan

Site Status

Iwate Medical University

Morioka, Iwate, Japan

Site Status

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Site Status

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Site Status

Saitama Sekishinkai Hospital

Sayama, Saitama, Japan

Site Status

Mitsui Memorial Museum

Chiyoda City, Tokyo, Japan

Site Status

Toho University Ohashi Medical Center

Meguro City, Tokyo, Japan

Site Status

Teikyo University

tabashi City, Tokyo, Japan

Site Status

Saiseikai Kumamoto Hospital

Kumamoto, , Japan

Site Status

Miyazaki Medical Association Hospital

Miyazaki, , Japan

Site Status

Sakurabashi Watanabe Hospital

Osaka, , Japan

Site Status

Countries

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Japan

References

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Nakamura M, Suzuki N, Fujii K, Furuya J, Kawasaki T, Kimura T, Sakamoto T, Tanabe K, Kusano H, Stockelman KA, Kozuma K. The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan. Circ J. 2024 May 24;88(6):863-872. doi: 10.1253/circj.CJ-23-0877. Epub 2024 Mar 13.

Reference Type DERIVED
PMID: 38479861 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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16-310

Identifier Type: -

Identifier Source: org_study_id

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