A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction

Myocardial Infarction Clinical Trial

— ISAR-Absorb MI  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01942070
• Other study ID #: Ge IDE No. I01210
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2013
• Est. completion date: March 2019

Study information

• Verified date: July 2018
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 262
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients 18 years or older with acute ST-elevation myocardial infarction or non ST-elevation myocardial infarction with angiographically confirmed thrombus

2. 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

3. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

4. In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

1. Target lesion located in the left main trunk

2. Severely calcified lesions

3. Bifurcation lesions with side branch diameter > 2mm

4. In-stent restenosis

5. Contraindications to antiplatelet therapy, cobalt chrome, everolimus, polylactic acid

6. 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

7. Pregnancy (present, suspected or planned) or positive pregnancy test.

8. Previous enrolment in this trial

9. Patient's inability to fully cooperate with the study protocol

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• Primary Angioplasty
• Thrombosis
• Thrombus

Intervention

Device:
• Bioresorbable vascular scaffold

• Durable polymer everolimus-eluting metallic stent

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Munich	Munich	Bavaria
Germany	Klinikum Rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Diameter Stenosis	Percentage diameter stenosis at coronary angiography at 6-8 months follow-up	6-8 months
Secondary	Device-oriented composite endpoint	Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR)	12 months
Secondary	Patient-oriented composite endpoint	The composite of death/any MI/all revascularization	12 months
Secondary	Composite of death or MI	The composite of cardiovascular death or MI	12 months
Secondary	Stent thrombosis	The incidence of scaffold or stent thrombosis	12 months