Coronary Artery Lesion
Conditions
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
Interventions
DEVICEABSORB scaffold
DEVICEXience
Sponsors
European Cardiovascular Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed