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

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

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

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Arterial Occlusive Diseases
• Intervention / Treatment: Device: Bioresorbable Vascular Scaffold

• Study Type: Observational
• Enrollment (Actual): 629

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seongnam, Korea, Republic of
    • Bundang CHA Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Wonju Severance Christian Hosp
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with Bioresorbable Vascular Scaffold

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bioresorbable Vascular Scaffold	Device: Bioresorbable Vascular Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
all death		5 years
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
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
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
Stroke		5 years
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

Collaborators and Investigators

• Sponsor: Duk-Woo Park, MD
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2016
• Primary Completion (Actual): March 23, 2019
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: November 29, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimated): December 4, 2015

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Bioresorbable Vascular Scaffold; Routine Clinical Practice; Angioplasty, Transluminal, Percutaneous Coronary; drug eluting stent
• Additional Relevant MeSH Terms: Heart Diseases; Vascular Diseases; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: AMCCV2015-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.