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

Coronary Artery Lesion Clinical Trial

— Compare Absorb  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02486068
• Other study ID #: COMPARE ABSORB
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 28, 2015
• Est. completion date: September 2024

Study information

• Verified date: August 2018
• Source: European Cardiovascular Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1670
• Est. completion date: September 2024
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Lesion

Intervention

Device:
• ABSORB scaffold

• Xience

Locations

Country	Name	City	State
Belgium	Cardiovascular Center Aalst OLV	Aalst
Belgium	CHR Citadelle	Leuven
Belgium	UZ Leuven	Leuven
Czechia	University Hospital Brno	Brno
Czechia	Cardiocentre, University Hospital Kralovske	Prague
Czechia	Central Military Hospital	Prague
France	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
Germany	Segeberger Kliniken	Bad Segeberg
Germany	Charité Campus Benjamin Franklin	Berlin
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Elisabethkrankenhaus Essen	Essen
Germany	Universitätsklinikum Gießen	Gießen
Germany	Universitätsklinikum Köln	Köln
Germany	Universität Leipzig - Herzzentrum	Leipzig
Germany	Universitätsmedizin Mainz	Mainz
Germany	Klinikum der Universität München	München
Italy	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	Padova
Italy	Arnas Civico Palermo	Palermo
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Albert Schweitzer Hospital	Dordrecht
Netherlands	Catherina Ziekenhuis	Eindhoven
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Maasstadziekenhuis	Rotterdam
Poland	American Heart of Poland	Chrzanów
Poland	University Hospital Krakow	Krakow
Poland	Miedziowe Centrum Zdrowia SA	Lubin
Poland	American Heart of Poland	Tychy
Spain	Hospital Clinic	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Marques de Valdecilla	Santander
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Freeman Hospital	Newcastle

Sponsors (1)

Lead Sponsor	Collaborator
European Cardiovascular Research Center

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	superiority of the Absorb to the Xience in TLF between 3 and 7 years		5 years
Secondary	Superiority of the Absorb to the Xience in TLF at 7 years		7 years
Secondary	Superiority of the Absorb to the XIence in cumulative angina rate at 1 year		1 year