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

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Lesion
• Interventions: Device: ABSORB scaffold; Device: Xience

• Registration Number: NCT02486068
• Lead Sponsor: European Cardiovascular Research Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-01
• Study Start: 2015-09-28
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14
• Primary Completion: 2018-08-28
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1670

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABSORB scaffold	ABSORB scaffold	Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold.
Xience	Xience	Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime.

Primary Outcome Measures

Name	Time	Method
non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)	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

Secondary Outcome Measures

Name	Time	Method
superiority of the Absorb to the Xience in TLF between 3 and 7 years	5 years
Superiority of the Absorb to the Xience in TLF at 7 years	7 years
Superiority of the Absorb to the XIence in cumulative angina rate at 1 year	1 year

Trial Locations

Locations (43)

Cardiovascular Center Aalst OLV; 🇧🇪 Aalst, Belgium

CHR Citadelle; 🇧🇪 Leuven, Belgium

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

American Heart of Poland; 🇵🇱 Tychy, Poland

University Hospital Krakow; 🇵🇱 Krakow, Poland

Azienda Ospedaliera Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Arnas Civico Palermo; 🇮🇹 Palermo, Italy

Clinique Pasteur; 🇫🇷 Toulouse, France

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Papworth Hospital; 🇬🇧 Cambridge, United Kingdom

UZ Leuven; 🇧🇪 Leuven, Belgium

Albert Schweitzer Hospital; 🇳🇱 Dordrecht, Netherlands

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Netherlands

Charité Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Miedziowe Centrum Zdrowia SA; 🇵🇱 Lubin, Poland

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Universitätsmedizin Mainz; 🇩🇪 Mainz, Germany

Università degli studi Magna Graecia; 🇮🇹 Catanzaro, Italy

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France

Clinique Saint-Hilaire; 🇫🇷 Rouen, France

Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Universität Leipzig - Herzzentrum; 🇩🇪 Leipzig, Germany

Catherina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Maasstadziekenhuis; 🇳🇱 Rotterdam, Netherlands

Azienda Ospedaliera Brotzu; 🇮🇹 Cagliari, Italy

Ospedale San Giacomo; 🇮🇹 Castelfranco Veneto, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Università degli Studi di Napoli Federico II; 🇮🇹 Napoli, Italy

Klinikum der Universität München; 🇩🇪 München, Germany

Azienda Ospedaliero-Universitaria di Parma; 🇮🇹 Parma, Italy

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain

University Hospital Brno; 🇨🇿 Brno, Czechia

Central Military Hospital; 🇨🇿 Prague, Czechia

Cardiocentre, University Hospital Kralovske; 🇨🇿 Prague, Czechia

Clinique Rhône Durance; 🇫🇷 Avignon, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Elisabethkrankenhaus Essen; 🇩🇪 Essen, Germany

Universitätsklinikum Gießen; 🇩🇪 Gießen, Germany

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom