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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1670

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitatsmedizin 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 Clinic
      • Barcelona, Spain, 8003
        • Hospital Del Mar
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Santander, Spain, 39008
        • Hospital Universitario Marqués 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Cardiovascular Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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