IRIS-BVS AMI Registry (IRIS BVS AMI)

Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Acute Myocardial Infarction; A Multicenter, Prospective Observational Study

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute myocardial infarction patients with Bioresorbable Vascular Scaffold

Description

Inclusion Criteria:

• Age 19 and more
• Acute myocardial infarction
• 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
acute myocardial infarction	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)	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All death		5years
Cardiac death		5years
Myocardial infarction		5years
Composite event of death or myocardial infarction		5years
Composite event of cardiac death or myocardial infarction		5years
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 %	5years
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.	5years
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;	5years
Stroke		5years
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	3days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Bioresorbable Vascular Scaffold; Routine Clinical Practice; Angioplasty, Transluminal, Percutaneous Coronary; drug eluting stent; acute myocardial infarction
• 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: AMCCV2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No