Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.

Official Title
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Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation

Conditions
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Stable Angina, Unstable Angina, NSTEMI

Intervention / Treatment
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* Device: Amphilimus Eluting Stent
* Device: Bare Metal Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years; Patients with symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia; Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG); Left ventricular ejection fraction > 30%; Patients presenting with at least two vessels disease requiring a staged procedure within 3 months, according to the operator judgement; Target de-novo lesion; Target lesion located in a target vessel with a diameter ranging from 2.5 to 3.75 mm; Target lesion diameter stenosis > 50% and < 100% by visual estimate, with a TIMI flow of >=1; Discrete lesion with a length ranging from 13 to 25 mm; The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (Cre8 or Vision/Multilink 8), according to the randomization arm; 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; Patient presenting with acute myocardial infarction with ST elevation; Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium; Cerebrovascular accident within the past 6 months; Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl); Thrombocytopenia (platelet count less than 100,000/mm³); Known bleeding or hypercoagulable disorder; Currently under immunosuppressant therapy; 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; Heavily calcified vessel and/or lesion which cannot be successfully predilated or imaged by OCT Target lesion is located or supplied by an arterial or venous bypass graft; Lesion located very distally, difficult to be imaged by OCT; Lesion located in angulated (>70°), sharp take-off vessel; Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter; Target lesion located in the left main stem; Ostial lesion location; Target lesion has TIMI 0 flow; Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRE8 arm<br> | Device: Amphilimus Eluting Stent<br>* Sirolimus formulated coronary eluting stent<br>|
| Active Comparator: Vision/Multilik8 arm<br> | Device: Bare Metal Stent<br>* Bare metal coronary stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT | 1 month for the BMS arm; 3 months for the DES arm | within 3 months from index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of malapposed stent struts |  | Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm) | 
| Percentage of malapposed and uncovered stent struts |  | 1 month (BMS arm) / 3 months (DES arm) | 
| Neointimal growth and neointimal thickness |  | 1 month (BMS arm) / 3 months (DES arm) | 
| Angiographic in-stent and in-segment endpoints | reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss | immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm) | 
| Clinical composite endpoints | Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR) | At 1, 3 and 12 months | 
| Stent Thrombosis |  | during index procedure, immediately after index procedure, 1 month, 3 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Optical Coherence Tomography, Tissue coverage, DES