Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population

Study Overview
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Brief Summary
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The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting Stent, in patients comparable to the everyday's clinical practice population, with a specific focus on diabetics, that will be part of a pre-specified study subgroup.

Official Title
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Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients

Conditions
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Stable Angina, Unstable Angina, Acute Myocardial Infarction

Intervention / Treatment
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* Device: Amphilimus Eluting Stent (CRE8)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years; Patients with symptoms of stable angina or documented silent ischemia; Patient with coronary artery disease ranging between 0 and 22 according to the Syntax score; Patients with acute coronary syndrome, including unstable angina, NSTEMI and STEMI; Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG); Left ventricular ejection fraction > 30%; Target de-novo lesions with diameter stenosis > 50% (including total occlusion); Target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm; Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site. Exclusion Criteria: Female with childbearing potential or lactating; Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium; Acute or chronic renal dysfunction (defined as creatinine greater than 2.5 mg/dl or on dialysis); Thrombocytopenia (platelet count less than 100,000/mm³) or hypercoagulable disorder; Known significant gastro-intestinal or urinary bleeding within the past 6 months; Patient refusing blood transfusion; Patient currently under immunosuppressant therapy; Patient with planned surgery within 6 months from the index procedure unless dual antiplatelet therapy is maintained throughout the peri-surgical period; Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year; Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study; Patient underwent target vessel revascularization with a DES within 3 months prior to the index procedure; Target lesion is located or supplied by an arterial or venous bypass graft.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amphilimus eluting stent (Cre8)<br>Sirolimus formulated coronary eluting stent | Device: Amphilimus Eluting Stent (CRE8)<br>* Sirolimus formulated coronary eluting stent<br>* Other names: CRE8;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization |  | At 30 days, 1 year and yearly up to 5 years | 
| Stent thrombosis |  | within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years | 
| Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup). | reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Drug Eluting Stent, All comers patients