Clinical Study Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems in the Treatment of Patients With Long de Novo Lesions.

Study Overview
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Brief Summary
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A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)]. The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures. All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure. 10% of the patients [(2:1) BioMime™ Morph (13) vs. Xience (7)] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. [Time Frame: Post-procedure and 6 months (±14 days)]

Official Title
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A Prospective, Active Control, Open-label, Multinational, Randomized Clinical Trial Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems to Evaluate Safety and Performance in Patients With Long de Novo Lesions.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: BioMime™ Morph - Sirolimus Eluting Coronary Stent System
* Device: Xience family Everolimus Coronary Stent Systems


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be at least ≥18 years of age. Significant de novo native coronary artery stenosis as part of Ischemic Heart Disease with lesion length of ≥26 mm and ≤56 mm (irrespective of number of lesions) with reference vessel diameter of (Proximal to Distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.50 - 3.00 mm. Patient with lesion(s), with a visually estimated stenosis of ≥50% and <100% with a TIMI flow of ≥1. Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure. This includes clinical trials of medication and invasive procedures, questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed. Female patient without childbearing potential who have either undergone surgical sterilization or is post-menopausal. Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent as approved by respective Ethics Committee and applicable Regulatory Authorities. Patient must agree to undergo all clinical investigations and follow up visits as per protocol. Exclusion Criteria: Patients with known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, anti-platelet medication specified for use in the study, everolimus and sirolimus, PLLA, PLGA, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. Pregnant or nursing patients or those who plan pregnancy in the period up to 2 years following index procedure(Pregnancy should be confirmed based on positive urine pregnancy test as part of screening procedure) An elective surgery planned within 6 months after the procedure that will require discontinuing of DAPT. Patient has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary). Patient has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK-MB/Troponin T/Troponin I values have not returned to within normal limits at the time of procedure. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure. Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant. Patient is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease. Patient with active bleeding disorders. Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a White Blood Cell count of <3,000 cells/mm3 or documented or suspected liver disease (including laboratory evidence of Hepatitis B and C) Known renal insufficiency (e.g., estimated Glomerular Filtration rate <60 ml/kg/m² or Serum Creatinine level of > 2.0 mg/dL, or patient on dialysis). Patient has had a Cerebrovascular Accident (CVA) or Transient Ischemic Neurological Attack (TIA) within the past 6 months. Patient belonging to a vulnerable population (per Investigator's judgment, e.g., subordinate hospital staff or Sponsor staff).

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: Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Active Control Device :- Xience family Everolimus Coronary Stent Systems
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioMime™ Morph - Sirolimus Eluting Coronary Stent System<br> | Device: BioMime™ Morph - Sirolimus Eluting Coronary Stent System<br>* Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].<br>|
| Active Comparator: Xience family Everolimus Coronary Stent Systems<br> | Device: Xience family Everolimus Coronary Stent Systems<br>* Active Control Device :- Xience family Everolimus Coronary Stent Systems Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) | Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or Ischemia-driven target lesion revascularization. | 6 months (±14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure | Target lesion failure is defined as a composite of cardiac death, myocardial infarction attributed to target vessel or ischemia-driven target lesion revascularization. | 1 month (± 7 days), 12 months (±1 month) and 24 months (±1 month) | 
| MACE | Major adverse cardiac event is defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven Target Lesion Revascularization (ID-TLR). | 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month) | 
| Stent Thrombosis Rate (As per Academic Research Consortium) | Stent thrombosis is defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers, probable (any unexplained death within the first 30 days), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis is categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation). | 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month) | 
| Ischemia-driven Target Vessel Revascularization (ID-TVR) | Ischemia-driven Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. | 1 month (± 7 days), 6 months (±14 days), 12 months (±1 month) and 24 months (±1 month) |