NCT01942070

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

4.5 years

First QC Date

September 10, 2013

Last Update Submit

July 6, 2018

Conditions

Cardiovascular DiseaseMyocardial InfarctionThrombusPrimary Angioplasty

Keywords

Cardiovascular DiseaseMyocardial InfarctionBioresorbable vascular scaffoldDurable polymer everolimus-eluting stentPrimary angioplastyStent

Outcome Measures

Primary Outcomes (1)

  • Percentage Diameter Stenosis

    Percentage diameter stenosis at coronary angiography at 6-8 months follow-up

    6-8 months

Secondary Outcomes (4)

  • Device-oriented composite endpoint

    12 months

  • Patient-oriented composite endpoint

    12 months

  • Composite of death or MI

    12 months

  • Stent thrombosis

    12 months

Study Arms (2)

Bioresorbable vascular scaffold

EXPERIMENTAL

Bioresorbable vascular scaffold (BVS)

Device: Bioresorbable vascular scaffold

Everolimus-eluting stent

ACTIVE COMPARATOR

Durable polymer everolimus-eluting metallic stent (EES)

Device: Durable polymer everolimus-eluting metallic stent

Interventions

Bioresorbable vascular scaffoldDEVICE
Also known as: ABSORB
Bioresorbable vascular scaffold
Durable polymer everolimus-eluting metallic stentDEVICE
Also known as: Xience
Everolimus-eluting stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum Munich

Munich, Bavaria, 80636, Germany

Location

Klinikum Rechts der Isar

Munich, Bavaria, 81675, Germany

Location

Related Publications (2)

  • Cassese S, Katagiri Y, Byrne RA, Brugaletta S, Alfonso F, Raber L, Maeng M, Iniguez A, Kretov E, Onuma Y, Joner M, Sabate M, Laugwitz KL, Windecker S, Kastrati A, Serruys PW. Angiographic and clinical outcomes of STEMI patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data. EuroIntervention. 2020 Mar 20;15(16):1451-1457. doi: 10.4244/EIJ-D-18-01080.

    PMID: 30719976DERIVED

  • Byrne RA, Alfonso F, Schneider S, Maeng M, Wiebe J, Kretov E, Bradaric C, Rai H, Cuesta J, Rivero F, Hoppmann P, Schlichtenmaier J, Christiansen EH, Cassese S, Joner M, Schunkert H, Laugwitz KL, Kastrati A. Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial. Eur Heart J. 2019 Jan 7;40(2):167-176. doi: 10.1093/eurheartj/ehy710.

    PMID: 30520980DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial InfarctionThrombosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisEmbolism and Thrombosis

Study Officials

  • Robert A Byrne, MB PhD

    Deutsches Herzzentrum Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations

DE(2)