SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent

Study Overview
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Brief Summary
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The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.

Detailed Description
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Series III Run-In is a prospective, multi-center, randomized, single-blind (patient-blind), non-inferiority trial to be conducted at approx. 35 interventional cardiology centers in India, Brazil, Argentina, Thailand and Saudi Aurabia. A total of 360 will be randomized on a 2:1 basis to either the Supralimus® (sirolimus-eluting) stent or the Xience V™ (everolimus-eluting) stent. In selected sites, IVUS will also be recorded in these patients (maximum of 60 IVUS patients in total), at baseline (post-procedure) and at 9-month follow-up. All patients will be followed clinically for up to 5 years after stent implantation. Repeat angiography will be performed in all patients at 9 months after the index procedure.

Official Title
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A Randomized Comparison of the Supralimus® Stent With the Xience V™ Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System
* Device: Xience V™ Everolimus Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age ≥18 years. Eligible for percutaneous coronary intervention (PCI) Acceptable candidate for CABG Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia. The target lesion is a single de novo coronary artery lesion with ≥ 50% and < 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion. The target lesion must be ≤ 22 mm in length by visual estimate. The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm. Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the clinical site. Exclusion Criteria: Female of childbearing potential Documented left ventricular ejection fraction (LVEF) ≤ 30% Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, everolimus, stainless steel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated) A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3 Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/L) Total occlusion (TIMI 0) or TIMI 1 Target vessel has evidence of thrombus Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment Previous bare metal stenting (less than 1 year) anywhere within the target vessel Previous drug-eluting stenting anywhere within any epicardial vessel The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.) Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated Target lesion is located in or supplied by an arterial or venous bypass graft Ostial target lesion Target lesion involves a side branch >2.0mm in diameter with an ostial disease Patient is currently participating in an investigational drug or device study, including its follow-up period Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed. Stroke or transient ischemic attack within the prior 6 months Unprotected Left Main (LM) coronary artery disease (stenosis >50%) In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study Planned surgery within 6 months after the index procedure Life expectancy less than 1 year

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supralimus(R) Sirolimus Eluting Stent<br>Supralimus® Coronary Stent System consisting of the MATRIX® Coronary Stent having Sirolimus eluting from Biodegradable Polymeric Matrix on a Stainless Steel Platform, Drug concentration 1.4 µg/mm2 | Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System<br>* Drug eluting stent implantation in the treatment of coronary artery disease.<br>* Other names: Drug Eluting Stent;|
| Active Comparator: Xience V™ Everolimus Eluting Stent<br>The XIENCE V™ Everolimus Eluting Coronary Stent System consisting of the MULTI-LINK VISION® Coronary Stent System coated with a formulation containing everolimus, the active ingredient, embedded in a non-erodible polymer., Drug Load: 100 µg/cm2 | Device: Xience V™ Everolimus Eluting Coronary Stent<br>* Drug eluting stent implantation in the treatment of coronary artery disease<br>* Other names: Drug Eluting Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent luminal late loss at 9 months after stent implantation (off-line QCA). |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate |  | Hospital discharge | 
| ANGIOGRAPHIC : Minimal lumen diameter (MLD), % diameter stenosis, In-segment late loss, Proximal late loss, Distal late loss, Binary restenosis rate |  | 9 months | 
| IVUS (in a subset of patients): Minimal lumen area, Vessel volume, Lumen volume, Neointimal hyperplasia, Volume obstruction, Incomplete stent apposition, Plaque behind the stent struts |  | 9 months | 
| DEVICE-ORIENTED COMPOSITE ENDPOINT : Cardiac death, MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR) |  | 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years | 
| PATIENT-ORIENTED COMPOSITE ENDPOINT : All-cause death, Any MI (including non-target vessel territory), Any repeat revascularization (including all target and non-target vessel) |  | 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years | 
| STENT THROMBOSIS |  | 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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restenosis, coronary artery disease, stent thrombosis, coronary stents, angioplasty, drug eluting stents