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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01942070
First received: September 10, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Myocardial Infarction
Thrombus
Primary Angioplasty
Device: Bioresorbable vascular scaffold
Device: Durable polymer everolimus-eluting metallic stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Percentage Diameter Stenosis [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
    Percentage diameter stenosis at coronary angiography at 6-8 months follow-up


Secondary Outcome Measures:
  • Device-oriented composite endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR)

  • Patient-oriented composite endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The composite of death/any MI/all revascularization

  • Composite of death or MI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The composite of cardiovascular death or MI

  • Stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The incidence of scaffold or stent thrombosis


Estimated Enrollment: 260
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bioresorbable vascular scaffold
Bioresorbable vascular scaffold (BVS)
Device: Bioresorbable vascular scaffold
Other Name: ABSORB
Active Comparator: Everolimus-eluting stent
Durable polymer everolimus-eluting metallic stent (EES)
Device: Durable polymer everolimus-eluting metallic stent
Other Name: Xience

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 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942070

Contacts
Contact: Robert A Byrne, MB PhD +49-89-1218 ext 4587 byrne@dhm.mhn.de
Contact: Simon Schneider, MD +49-89-4041 ext 0 simon-schneider@tum.de

Locations
Germany
Deutsches Herzzentrum Munich Recruiting
Munich, Bavaria, Germany, 80636
Contact: Robert A Byrne, MD    +49-89-1218 ext 4587    byrne@dhm.mhn.de   
Contact: ISAResearch Team    +49-89-1218 ext 1534      
Principal Investigator: Robert A Byrne, MB PhD         
Klinikum Rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Simon Schneider, MD    +49-89-4140 ext 0    simon-schneider@tum.de   
Principal Investigator: Simon Schneider, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Robert A Byrne, MB PhD Deutsches Herzzentrum Munich
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01942070     History of Changes
Other Study ID Numbers: Ge IDE No. I01210
Study First Received: September 10, 2013
Last Updated: October 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
Cardiovascular Disease
Myocardial Infarction
Bioresorbable vascular scaffold
Durable polymer everolimus-eluting stent
Primary angioplasty
Stent

Additional relevant MeSH terms:
Cardiovascular Diseases
Infarction
Myocardial Infarction
Thrombosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Embolism and Thrombosis
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014