ISAR-Absorb MI: A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction

Sponsor

Deutsches Herzzentrum Muenchen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01942070

Collaborator

(none)

262

Enrollment

Locations

Arms

65.9

Anticipated Duration (Months)

131

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease Myocardial Infarction Thrombus Primary Angioplasty	Device: Bioresorbable vascular scaffold Device: Durable polymer everolimus-eluting metallic stent	N/A

Detailed Description

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation currently represents the dominant treatment strategy in patients undergoing catheter intervention. However effective neointimal suppression occurs at the cost of a systematic delay in arterial healing in comparison with after bare metal stenting. This underlies a small but significant increased risk of stent thrombosis after DES implantation in comparison with bare metal stent implantation as well as a possible excess of in-stent neoatheroma formation.

Bioresorbable vascular scaffolds (BVS) represent an innovative technology providing short-term vessel scaffolding and drug delivery without the long-term limitations of metallic DES and durable polymer coatings. Potential benefits include restoration of normal vasomotor reactivity, facilitation of positive vessel wall remodelling and facilitation of subsequent bypass grafting of the stented arterial segment. In addition preliminary reports suggest that the process of scaffold biodegradation may promote formation of a cohesive tissue layer covering and stabilizing the underlying atherosclerotic plaque - a so-called plaque-sealing effect. Although initial results with BVS are encouraging, there is a lack of randomized clinical trial data and no data exists for outcomes after BVS implantation in patients undergoing coronary stenting in the setting of acute myocardial infarction (MI).

The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI. The primary endpoint will be percentage diameter stenosis at protocol-mandated 6-8 month angiographic follow-up. Sample size calculation is based on a non-inferiority assumption in relation to the BVS versus EES. It is planned to enrol a total of 260 patients. Subsequent clinical follow-up will be undertaken out to 2 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

262 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intracoronary Scaffold Assessment a Randomised Evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction

Actual Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bioresorbable vascular scaffold Bioresorbable vascular scaffold (BVS)	Device: Bioresorbable vascular scaffold Other Names: ABSORB
Active Comparator: Everolimus-eluting stent Durable polymer everolimus-eluting metallic stent (EES)	Device: Durable polymer everolimus-eluting metallic stent Other Names: Xience

Arm

Intervention/Treatment

Experimental: Bioresorbable vascular scaffold

Bioresorbable vascular scaffold (BVS)

Device: Bioresorbable vascular scaffold

Other Names:

ABSORB

Active Comparator: Everolimus-eluting stent

Durable polymer everolimus-eluting metallic stent (EES)

Device: Durable polymer everolimus-eluting metallic stent

Other Names:

Xience

Outcome Measures

Primary Outcome Measures

Percentage Diameter Stenosis [6-8 months]
Percentage diameter stenosis at coronary angiography at 6-8 months follow-up

Secondary Outcome Measures

Device-oriented composite endpoint [12 months]
Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR)
Patient-oriented composite endpoint [12 months]
The composite of death/any MI/all revascularization
Composite of death or MI [12 months]
The composite of cardiovascular death or MI
Stent thrombosis [12 months]
The incidence of scaffold or stent thrombosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients 18 years or older with acute ST-elevation myocardial infarction or non ST-elevation myocardial infarction with angiographically confirmed thrombus
Planned stent implantation in de novo lesions in native vessels or coronary bypass grafts with reference vessel diameter ≥2.5 mm and ≤3.9 mm
Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

Target lesion located in the left main trunk
Severely calcified lesions
Bifurcation lesions with side branch diameter > 2mm
In-stent restenosis
Contraindications to antiplatelet therapy, cobalt chrome, everolimus, polylactic acid
Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance
Pregnancy (present, suspected or planned) or positive pregnancy test.
Previous enrolment in this trial
Patient's inability to fully cooperate with the study protocol