ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis (Compare Absorb)

August 13, 2018 updated by: European Cardiovascular Research Center

ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis

The primary objectives of this trial are:

In patients at high-risk for restenosis,

  • To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
  • To assess superiority of the BRS to the EES in TLF between 3 and 7 years

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1670

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Cardiovascular Center Aalst OLV
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Leuven, Belgium, 3000
        • CHR Citadelle
  • Czechia
      • Brno, Czechia, 62500
        • University Hospital Brno
      • Prague, Czechia, 10034
        • Cardiocentre, University Hospital Kralovske
      • Prague, Czechia, 1200
        • Central Military Hospital
  • France
      • Avignon, France, 84082
        • Clinique Rhône Durance
      • Clermont-Ferrand, France, 63000
        • Chu Clermont-Ferrand
      • Massy, France, 91300
        • Hôpital privé Jacques Cartier
      • Rouen, France, 76000
        • Clinique Saint-Hilaire
      • Toulouse, France, 31300
        • Clinique Pasteur
  • Germany
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Essen, Germany, 45138
        • Elisabethkrankenhaus Essen
      • Gießen, Germany, 33539
        • Universitätsklinikum Gießen
      • Köln, Germany, 50937
        • Universitätsklinikum Köln
      • Leipzig, Germany, 04289
        • Universität Leipzig - Herzzentrum
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz
      • München, Germany, 81377
        • Klinikum der Universität München
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Cagliari, Italy, 09134
        • Azienda Ospedaliera Brotzu
      • Castelfranco Veneto, Italy, 31033
        • Ospedale San Giacomo
      • Catanzaro, Italy, 88100
        • Università degli Studi Magna Graecia
      • Napoli, Italy, 80131
        • Università Degli Studi Di Napoli Federico Ii
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
      • Palermo, Italy, 90127
        • Arnas Civico Palermo
      • Parma, Italy, 43126
        • Azienda Ospedaliero-Universitaria di Parma
  • Netherlands
      • Breda, Netherlands, 4818
        • Amphia Ziekenhuis
      • Dordrecht, Netherlands, 3300
        • Albert Schweitzer Hospital
      • Eindhoven, Netherlands, 5623
        • Catherina ziekenhuis
      • Rotterdam, Netherlands, 3000
        • Erasmus Medisch Centrum
      • Rotterdam, Netherlands, 3079
        • Maasstadziekenhuis
  • Poland
      • Chrzanów, Poland, 40-635
        • American Heart of Poland
      • Krakow, Poland, 31-501
        • University Hospital Krakow
      • Lubin, Poland, 59-301
        • Miedziowe Centrum Zdrowia SA
      • Tychy, Poland, 43-100
        • American Heart of Poland
  • Spain
      • Barcelona, Spain, 8036
        • Hospital Clínic
      • Barcelona, Spain, 8003
        • Hospital del Mar
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Hospital
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients (18-75 years old) with at least one of the followings:

  • High-risk characteristics for restenosis

    • Medically treated Diabetes (oral medication or insulin)
    • Multivessel disease of which more than one de-novo target lesion to be treated with the study scaffold/stent

  • Complex target lesion

    • Single de-novo target lesion satisfying at least one of the following:
    • Lesion length >28 mm
    • Small vessels: Target lesion reference vessel diameter between ≥2.5 mm and ≤2.75mm
    • Lesion with pre-existing total occlusion (pre-procedural TIMI = 0)
    • Bifurcation with single stent strategy

Exclusion Criteria:

  • Patients are excluded from this study if they have:
  • Age <18 years or >75 years
  • Known comorbidities which make patients unable to complete 7-years follow-up
  • Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
  • Pregnant woman
  • Breastfeeding woman
  • Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
  • Cardiogenic Shock (Killip >2)
  • PCI with implantation of stents/scaffolds within previous 30 days.
  • Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
  • Renal insufficiency (GFR <45 ml/min)
  • Life expectancy < 7 years
  • Known non-adherence to DAPT
  • Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban)
  • LVEF <30%
  • Patients at high bleeding risk who are not suitable for long-term DAPT

  • Following lesion characteristics:

    • Target lesion reference vessel diameter (RVD) < 2.5 and > 4 mm
    • STEMI with RVD of >3.5mm of the culprit target lesion
    • Target lesion with in-stent/scaffold thrombosis
    • Graft lesions as target lesions
    • Aorto-ostial lesion(s)
    • Left main lesion
    • Severe tortuosity of target vessel
    • In-scaffold restenosis
    • Bifurcation target lesion with intended 2 stent/scaffold strategy
  • Non-target lesion and target lesion in the same epicardial coronary artery (right coronary artery, left circumflex artery or left anterior descending artery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABSORB scaffold
Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold.
Device: ABSORB scaffold
Active Comparator: Xience
Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime.
Device: Xience

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)
Time Frame: 1 year

Composite of:

  • Cardiac death
  • Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI)
  • Clinically Indicated Target lesion revascularization
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
superiority of the Absorb to the Xience in TLF between 3 and 7 years
Time Frame: 5 years
5 years
Superiority of the Absorb to the Xience in TLF at 7 years
Time Frame: 7 years
7 years
Superiority of the Absorb to the XIence in cumulative angina rate at 1 year
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Cardiovascular Research Center

Investigators

  • Principal Investigator: Pieter Smits, MD, Maastad hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2015

Primary Completion (Anticipated)

August 28, 2018

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • COMPARE ABSORB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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