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

Terminated

• Conditions: Coronary Artery Disease; Arterial Occlusive Diseases; Coronary Disease; Cardiovascular Diseases
• Interventions: Device: Bioresorbable Vascular Scaffold

• Registration Number: NCT02622100
• Lead Sponsor: Duk-Woo Park, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-29
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Study Start: 2016-02-26
• Primary Completion: 2019-03-23
• Status Verified: 2023-12
• Study Completion: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 629

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bioresorbable Vascular Scaffold	Bioresorbable Vascular Scaffold	-

Primary Outcome Measures

Name	Time	Method
Composite event	1 year	The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

Secondary Outcome Measures

Name	Time	Method
cardiac death	5 years
Composite event of death or myocardial infarction	5 years
Stroke	5 years
all death	5 years
myocardial infarction	5 years
Target Vessel revascularization	5 years	Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.; Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve).; Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %
Composite event of cardiac death or myocardial infarction	5 years
Target Lesion revascularization	5 years	Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Stent thrombosis	5 years	DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: \>24 hours to 30 days post; late stent thrombosis: \>30 days to 1 year post; Very late stent thrombosis: \>1 year post;
Procedural success	3 days	Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death

Trial Locations

Locations (14)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

ChonBuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Bundang CHA Hospital; 🇰🇷 Seongnam, Korea, Republic of

Wonju Severance Christian Hosp; 🇰🇷 Wonju, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of