ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
NCT ID: NCT02486068
Last Updated: 2018-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1670 participants
INTERVENTIONAL
2015-09-28
2024-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ABSORB scaffold
Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold.
ABSORB scaffold
Xience
Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime.
Xience
Interventions
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ABSORB scaffold
Xience
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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European Cardiovascular Research Center
NETWORK
Responsible Party
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Principal Investigators
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Pieter Smits, MD
Role: PRINCIPAL_INVESTIGATOR
Maastad hospital
Locations
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Cardiovascular Center Aalst OLV
Aalst, , Belgium
CHR Citadelle
Leuven, , Belgium
UZ Leuven
Leuven, , Belgium
University Hospital Brno
Brno, , Czechia
Cardiocentre, University Hospital Kralovske
Prague, , Czechia
Central Military Hospital
Prague, , Czechia
Clinique Rhône Durance
Avignon, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Privé Jacques Cartier
Massy, , France
Clinique Saint-Hilaire
Rouen, , France
Clinique Pasteur
Toulouse, , France
Segeberger Kliniken
Bad Segeberg, , Germany
Charité Campus Benjamin Franklin
Berlin, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Elisabethkrankenhaus Essen
Essen, , Germany
Universitätsklinikum Gießen
Giessen, , Germany
Universität Leipzig - Herzzentrum
Leipzig, , Germany
Universitätsmedizin Mainz
Mainz, , Germany
Klinikum der Universität München
München, , Germany
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Azienda Ospedaliera Brotzu
Cagliari, , Italy
Ospedale San Giacomo
Castelfranco Veneto, , Italy
Università degli studi Magna Graecia
Catanzaro, , Italy
Università degli Studi di Napoli Federico II
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Arnas Civico Palermo
Palermo, , Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Amphia Ziekenhuis
Breda, , Netherlands
Albert Schweitzer Hospital
Dordrecht, , Netherlands
Catherina Ziekenhuis
Eindhoven, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Maasstadziekenhuis
Rotterdam, , Netherlands
American Heart of Poland
Chrzanów, , Poland
University Hospital Krakow
Krakow, , Poland
Miedziowe Centrum Zdrowia SA
Lubin, , Poland
American Heart of Poland
Tychy, , Poland
Hospital del Mar
Barcelona, , Spain
Hospital Clinic
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Papworth Hospital
Cambridge, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Countries
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References
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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.
Other Identifiers
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COMPARE ABSORB
Identifier Type: -
Identifier Source: org_study_id
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