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

Study Overview
=================
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

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

Conditions
-----------------
Coronary Artery Lesion

Intervention / Treatment
-----------------
* Device: ABSORB scaffold
* Device: Xience


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABSORB scaffold<br>Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold. | Device: ABSORB scaffold<br> <br> |
| Active Comparator: Xience<br>Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime. | Device: Xience<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |