ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
- Conditions
- Coronary Artery Lesion
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1670
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
-
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
- 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
Related Research Topics
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Trial Locations
- Locations (43)
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
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