IRIS-BVS AMI Registry

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StatusTerminated

Keywords

Abstract

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.

Dates

Last Verified:	11/30/2017
First Submitted:	02/29/2016
Estimated Enrollment Submitted:	02/29/2016
First Posted:	03/03/2016
Last Update Submitted:	12/17/2017
Last Update Posted:	12/19/2017
Actual Study Start Date:	05/31/2016
Estimated Primary Completion Date:	11/30/2017
Estimated Study Completion Date:	11/30/2017

Condition or disease

Arterial Occlusive Diseases

Cardiovascular Diseases

Coronary Artery Disease

Intervention/treatment

Device: acute myocardial infarction

Phase

Arm Groups

Arm	Intervention/treatment
acute myocardial infarction	Device: acute myocardial infarction

Eligibility Criteria

Ages Eligible for Study	19 Years To 19 Years
Sexes Eligible for Study	All
Sampling method	Non-Probability Sample
Accepts Healthy Volunteers	Yes
Criteria	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

Outcome

Primary Outcome Measures

1. Composite event [1year]

The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

Secondary Outcome Measures

1. all death [5years]

2. cardiac death [5years]

3. myocardial infarction [5years]

4. Composite event of death or myocardial infarction [5years]

5. Composite event of cardiac death or myocardial infarction [5years]

6. Target Vessel revascularization [5years]

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 %

7. Target Lesion revascularization [5years]

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.

8. Stent thrombosis [5years]

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;

9. Procedural success [3days]

Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death