XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

Study Overview
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Brief Summary
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The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty

Detailed Description
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The present clinical investigation is designed as a prospective, multicentre, international, randomized, open label, 2-arm parallel group, trial in patients undergoing Percutaneous Coronary Intervention (PCI) comparing Xlimus DES versus Synergy DES with respect to optical coherence tomography (OCT) derived measures at 6-month Follow Up (FU) and clinical events at 12 months after procedure. A total of 180 patients will be recruited and randomized in the two groups in a 2:1 ratio. After index procedure, patients will be followed up by angiographic follow-up at 6 months and clinical follow-up at 12 months.The primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment

Official Title
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XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Xlimus DES Implantation during coronary angioplasty
* Device: Synergy DES Implantation during coronary angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI. PCI considered appropriate and feasible Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for implantation with either study stent (no limitation on the number of treated lesions, vessel and lesion length); Patient provides written informed consent Patient agrees to all required follow-up procedures and visits. Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm Exclusion Criteria: The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus or its derivatives, everolimus or structurally-related compounds, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled); Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum; Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer; Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study and not using adequate contraceptive methods; History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions; Previous coronary intervention on target vessel in the 3-months prior to enrollment; Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment); Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period; Previously documented left ventricular ejection fraction (LVEF) <30%; Evident cardiogenic shock before randomization; Patients with left main stem stenosis (>50% by visual estimate); In-stent restenosis; ST-segment elevation MI; Chronic total occlusion/ heavily calcified lesions Culprit lesion to a Saphenous Vein 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized multi-centre controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XLIMUS DES<br>Xlimus DES Implantation during coronary angioplasty | Device: Xlimus DES Implantation during coronary angioplasty<br>* Xlimus DES Implantation during coronary angioplasty<br>|
| Active Comparator: Synergy DES<br>Synergy DES Implantation during coronary angioplasty | Device: Synergy DES Implantation during coronary angioplasty<br>* Synergy DES Implantation during coronary angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent neointimal volume | In-stent neointimal volume at 6-month follow-up, measured with OCT, as assessed by the Core-Lab. Neointimal volume will be calculated in all analyzed cross-sections and volumetric measurements and in stent neointimal volume will be compared in the two groups. | 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal area | Neointimal area calculated at the site of minimal lumen area measured with OCT | 6-month follow-up | 
| Number of Target lesion failure | composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR) | 12-months follow-up | 
| Number of patients experiencig Cardiac death | Any death due to proximate cardiac cause (eg, MI, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death | 12-months follow-up | 
| Number of Target-vessel Myocardial infarction | any MI that, irrespective of the time after the index procedure, is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. Type of acute MI is classified according to the Joint ESC/ACCF/AHA/ WHF Joint Task Force for the Universal Definition of Myocardial Infarction | 12-months follow-up | 
| Number of Target-lesion revascularization | repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI | 12-months follow-up | 
| Number of Stent thrombosis | This is defined according to classification proposed by the Academic Research Consortium | 12-months follow-up | 
| Percentage of Device success at 24 hours | deployment of the assigned stents without system failure or device-related complication | 24 hours | 
| Percentage of Lesion success at 24 hours | attainment of <50% residual stenosis of the target lesion using post-PCI | 24 hours | 
| Percentage of Procedural success at 24 hours | lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay | 24 hours |