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

Coronary Artery Disease Clinical Trial

— IRIS BVS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02622100
• Other study ID #: AMCCV2015-11
• Status: Terminated
• Start date: February 26, 2016
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 629
• Est. completion date: December 2023
• Est. primary completion date: March 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Bioresorbable Vascular Scaffold

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	ChonBuk National University Hospital	Jeonju
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Wonju Severance Christian Hosp	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Duk-Woo Park, MD	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	all death		5 years
Secondary	cardiac death		5 years
Secondary	myocardial infarction		5 years
Secondary	Composite event of death or myocardial infarction		5 years
Secondary	Composite event of cardiac death or myocardial infarction		5 years
Secondary	Target Vessel revascularization	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 %	5 years
Secondary	Target Lesion revascularization	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.	5 years
Secondary	Stent thrombosis	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;	5 years
Secondary	Stroke		5 years
Secondary	Procedural success	Defined as mean lesion diameter stenosis =50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death	3 days