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

September 10, 2013
October 30, 2013
September 2013
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01942070 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cardiovascular Disease
  • Myocardial Infarction
  • Thrombus
  • Primary Angioplasty
  • Device: Bioresorbable vascular scaffold
    Other Name: ABSORB
  • Device: Durable polymer everolimus-eluting metallic stent
    Other Name: Xience
  • Experimental: Bioresorbable vascular scaffold
    Bioresorbable vascular scaffold (BVS)
    Intervention: Device: Bioresorbable vascular scaffold
  • Active Comparator: Everolimus-eluting stent
    Durable polymer everolimus-eluting metallic stent (EES)
    Intervention: Device: Durable polymer everolimus-eluting metallic stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Germany
 
NCT01942070
Ge IDE No. I01210
Yes
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Not Provided
Principal Investigator: Robert A Byrne, MB PhD Deutsches Herzzentrum Munich
Deutsches Herzzentrum Muenchen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP