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

Sponsor

Duk-Woo Park, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT02622100

Collaborator

CardioVascular Research Foundation, Korea (Other)

1,000

Enrollment

Locations

87.1

Anticipated Duration (Months)

71.4

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Occlusive Diseases Cardiovascular Diseases Coronary Artery Disease Coronary Disease	Device: Bioresorbable Vascular Scaffold

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Actual Study Start Date :

Feb 26, 2016

Actual Primary Completion Date :

Mar 23, 2019

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Bioresorbable Vascular Scaffold	Device: Bioresorbable Vascular Scaffold

Arm

Intervention/Treatment

Bioresorbable Vascular Scaffold

Device: Bioresorbable Vascular Scaffold

Outcome Measures

Primary Outcome Measures

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

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]
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 %
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;
Stroke [5 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	138-736
2	Hallym University Sacred Heart Hospital	Anyang		Korea, Republic of
3	Gangwon National Univ. Hospital	Chuncheon		Korea, Republic of
4	Daegu Catholic University Medical Center	Daegu		Korea, Republic of
5	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
6	Chungnam National University Hospital	Daejeon		Korea, Republic of
7	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon		Korea, Republic of
8	Gangneung Asan Hospital	Gangneung		Korea, Republic of
9	Chonnam National University Hospital	Gwangju		Korea, Republic of
10	ChonBuk National University Hospital	Jeonju		Korea, Republic of
11	Dong-A Medical Center	Pusan		Korea, Republic of
12	Bundang CHA Hospital	Seongnam		Korea, Republic of
13	Korea University Guro Hospital	Seoul		Korea, Republic of
14	Ulsan University Hospital	Ulsan		Korea, Republic of