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

NCT02486068 | Unknown DMC

• 1 other identifier: COMPARE ABSORB
• Study Type: interventional
• Target: 1,670
• Locations: 9 countries
• Sites: 44

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

Conditions

Coronary Artery Lesion

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• 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

Study Arms (2)

ABSORB scaffold

EXPERIMENTAL

Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold.

Device: ABSORB scaffold

Xience

ACTIVE COMPARATOR

Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime.

Device: Xience

Interventions

ABSORB scaffold DEVICE

ABSORB scaffold

Xience DEVICE

Xience

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Cardiovascular Research Center: lead

Study Sites (44)

Cardiovascular Center Aalst OLV

Aalst, 9300, Belgium

Location

CHR Citadelle

Leuven, 3000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

University Hospital Brno

Brno, 62500, Czechia

Location

Cardiocentre, University Hospital Kralovske

Prague, 10034, Czechia

Location

Central Military Hospital

Prague, 1200, Czechia

Location

Clinique Rhône Durance

Avignon, 84082, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Clinique Saint-Hilaire

Rouen, 76000, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Elisabethkrankenhaus Essen

Essen, 45138, Germany

Location

Universitätsklinikum Gießen

Giessen, 33539, Germany

Location

Universität Leipzig - Herzzentrum

Leipzig, 04289, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Azienda Ospedaliera Brotzu

Cagliari, 09134, Italy

Location

Ospedale San Giacomo

Castelfranco Veneto, 31033, Italy

Location

Università degli studi Magna Graecia

Catanzaro, 88100, Italy

Location

Università degli Studi di Napoli Federico II

Napoli, 80131, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Arnas Civico Palermo

Palermo, 90127, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

Location

Amphia Ziekenhuis

Breda, 4818, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, 3300, Netherlands

Location

Catherina Ziekenhuis

Eindhoven, 5623, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3000, Netherlands

Location

Maasstadziekenhuis

Rotterdam, 3079, Netherlands

Location

American Heart of Poland

Chrzanów, 40-635, Poland

Location

University Hospital Krakow

Krakow, 31-501, Poland

Location

Miedziowe Centrum Zdrowia SA

Lubin, 59-301, Poland

Location

American Heart of Poland

Tychy, 43-100, Poland

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital Clinic

Barcelona, 8036, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Papworth Hospital

Cambridge, CB23 3RE, United Kingdom

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

Related Publications (1)

• Chang CC, Onuma Y, Achenbach S, Barbato E, Chevalier B, Cook S, Dudek D, Escaned J, Gori T, Kocka V, Tarantini G, West NEJ, Morice MC, Tijssen JGP, van Geuns RJ, Smits PC; COMPARE ABSORB trial investigators. Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. Cardiovasc Revasc Med. 2019 Jul;20(7):577-582. doi: 10.1016/j.carrev.2019.04.013. Epub 2019 Apr 16.

  PMID: 31153846 DERIVED

Study Officials

• Pieter Smits, MD

  Maastad hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 1, 2015
• Study Start: September 28, 2015
• Primary Completion: August 28, 2018
• Study Completion: September 1, 2024
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

DE (9); BE (3); FR (5); IT (8); NL (5); PL (4); CZ (3); ES (4); GB (3)