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

NCT02622100 | Terminated DMC

• 1 other identifier: AMCCV2015-11
• Study Type: observational
• Target: 629
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Arterial Occlusive Diseases; Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite event

  The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

  1 year

Secondary Outcomes (10)

• all death

  5 years

• cardiac death

  5 years

• myocardial infarction

  5 years

• Composite event of death or myocardial infarction

  5 years

• Composite event of cardiac death or myocardial infarction

  5 years

Study Arms (1)

Bioresorbable Vascular Scaffold

Device: Bioresorbable Vascular Scaffold

Interventions

Bioresorbable Vascular Scaffold DEVICE

Bioresorbable Vascular Scaffold

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with Bioresorbable Vascular Scaffold

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duk-Woo Park, MD: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (14)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

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

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

ChonBuk National University Hospital

Jeonju, South Korea

Location

Bundang CHA Hospital

Seongnam, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Wonju Severance Christian Hosp

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Myocardial Ischemia; Heart Diseases; Arteriosclerosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 29, 2015
• First Posted: December 4, 2015
• Study Start: February 26, 2016
• Primary Completion: March 23, 2019
• Study Completion: December 1, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (14)