Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice

NCT ID: NCT02622100

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

629 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-26

Study Completion Date

2023-12-31

Brief Summary

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The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.

Detailed Description

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Conditions

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Arterial Occlusive Diseases Cardiovascular Diseases Coronary Artery Disease Coronary Disease

Keywords

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Bioresorbable Vascular Scaffold Routine Clinical Practice Angioplasty, Transluminal, Percutaneous Coronary Coronary Artery Disease drug eluting stent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bioresorbable Vascular Scaffold

Bioresorbable Vascular Scaffold

Intervention Type DEVICE

Interventions

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Bioresorbable Vascular Scaffold

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 19 and more
* Intervention with Bioresorbable Vascular Scaffold
* Agreed with written informed consent form

Exclusion Criteria

* Bypass graft surgery (CABG) recommended
* Lesion with previous bypass graft surgery (CABG)
* Severe calcification and/or severe tortuosity
* Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
* Life expectancy of 1year and under
* Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
* Cardiac shock
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Duk-Woo Park, MD

OTHER

Sponsor Role lead

Responsible Party

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Duk-Woo Park, MD

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Gangwon National Univ. Hospital

Chuncheon, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, , South Korea

Site Status

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

ChonBuk National University Hospital

Jeonju, , South Korea

Site Status

Bundang CHA Hospital

Seongnam, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Wonju Severance Christian Hosp

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMCCV2015-11

Identifier Type: -

Identifier Source: org_study_id