Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions

Study Overview
=================
Brief Summary
-----------------
1.) Indigenously developed and designed BioMimeTM is a predictably safe & efficacious 3rd generation drug eluting stent (DES) with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut thickness Co-Cr stent, highly documented drug Sirolimus & a biocompatible, biodegradable polymer

Detailed Description
-----------------
Principal Investigator: Dr. Sameer Dani, Interventional Cardiologist, Life Care Hospital, Ahmedbad. Mobile +91 98250 38855. Study Title: The First-In-Man Safety and Performance Evaluation of the BiomimeTM Sirolimus-Eluting Stent System for the Treatment of Patients with Single, De novo, Non-complex Coronary Lesions - The BiomimeTM Pilot FiM Trial Sponsor: Meril Life Sciences Pvt. Ltd. Study device: BiomimeTM Sirolimus-Eluting Stent (BiomimeTM SES, Meril Life Sciences) Study objective: To evaluate the safety and efficacy of BiomimeTM SES. Study design: Phase IV, prospective study to be conducted in a single centre (Life Care Hospital, Ahmedbad) Study population: A total of 30 patients with stable or unstable coronary disease, or silent ischemia with documented evidence of ischemia, with angiography, and, in a pre-specified subset, intravascular ultrasound (IVUS) at 8-month follow-up. Participating Centre: Life Care Hospital, Ahmedabad QCA & IVUS core lab: To be decided. Follow-up: All patients will undergo clinical follow-up at 1, 6, 12 and 24 months. All patients will undergo angiographic follow-up at 8 months. All patients will be submitted to intravascular ultrasound at 8 months. Primary safety endpoint: Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR). Primary efficacy endpoint: In-stent luminal loss assessed by quantitative coronary angiography (QCA) at 8-month follow-up Percentage of in-stent volume obstruction measured by IVUS at 8- month follow-up. Secondary endpoints: Occurrence of Major Adverse Cardiac Events (MACE) defined as cardiac death, non-fatal acute myocardial infarction, and need for repeat target-lesion revascularization (by cardiac bypass graft or repeat percutaneous coronary intervention up to 24 months of follow-up. Angiographic binary restenosis at 8 months angiographic follow-up. Other endpoints: Rates of stent thrombosis (acute, sub-acute, late and very-late) up to 24 months follow-up In-stent and in-segment minimum lumen diameter (MLD) and % diameter stenosis (DS) by QCA at 8-month angiographic follow-up. In-stent acute gain by post procedure QCA. Late acquired incomplete stent apposition by IVUS at 8 month follow-up. Primary analysis: The primary endpoint will be analyzed for all subjects who had a de novo coronary lesion enrolled in this study (intention to treat)

Official Title
-----------------
The First-In-Man Safety and Performance Evaluation of the Biomime Sirolimus Eluting Stent System for the Treatment of Patients With Single, De Novo, Non-Complex Coronary Lesions-The Biomime Pilot FiM Trial.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Sirolimus Eluting Coronary Stent System (Biomime)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with > 18 years of age; Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia; Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents; Acceptable candidate for coronary artery bypass graft (CABG) surgery; The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups, including angiographic (and IVUS) follow-ups at 8 months. Target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by visual estimation) Target lesions ≤ 19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length); ≥ 50% and < 100% diameter stenosis; TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2. Exclusion Criteria: Known hypersensitivity or contraindication to mTOR inhibitor class drugs (sirolimus), heparin, any required medications including thienopyridines, cobalt chromium, and contrast media which cannot be adequately pre medicated; Patient is a female with childbearing potential; Pre-treatment of the target lesion with any devices other than balloon angioplasty; Previous brachytherapy in the target vessel; Presence of non-target vessel lesions which require staged procedure(s) < 30 days of the index procedure; Prior CABG surgery to target vessel; Previous percutaneous coronary intervention (PCI) or CABG surgery < 30 days to the index procedure date; Acute myocardial infarction < 3 days, with cardiac enzyme elevation including total creatine kinase (CK) > 2 times the upper normal limit value and/or CK-MB above the upper normal limit value within the past 72 hours; CK and/or CK-MB levels elevated above the upper normal limit value at the time of the index procedure; Documented left ventricular ejection fraction < 30%; Renal insufficiency determined by a baseline serum creatinine > 2.0/dl; Thrombocytopenia with a baseline platelet count < 100,000 cells/mm3; Anemia with baseline hemoglobin < 10g/dL; Extensive peripheral vascular disease or extreme anticoagulation that precludes safe > 5 French sheath insertion; History of bleeding diathesis, coagulopathy, or will refuse blood transfusions; Patients has suffered a stroke, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within the past 6 months; Significant gastrointestinal or genitourinary bleed within the past 6 months; Patient is a recipient of a heart transplant; Any elective surgical procedure is planned within 12 months of the index procedure; Known illness or any serious clinical condition with life expectancy < 2 years; Participation in the active or follow-up phase of any other clinical trial within 6 months; Impossibility to comply with anti-platelet therapy during the study clinical follow-up; Any impossibility to comply with all protocol follow-ups. Target lesion or vessel with angiographic evidence of moderate or severe calcification; Presence of severe tortuosity; Presence of severe angulation (> 60o); Presence of intraluminal thrombus; Target lesion involving a bifurcation (side branch ≥ 2.0mm); Target lesion located in the left main stem; Aorto-ostial lesion location; Target lesion involving a side branch with reference diameter ≥ 2.0mm; Presence of a significant stenosis (> 40%) in the target vessel either proximal or distal to the target lesion that will be untreated; Previous placement of a stent within 10mm of the target lesion; Total occlusion (TIMI flow grade 0 or 1); Target lesion located in an arterial or vein graft; Target lesion due to in-stent restenosis; Coronary anatomy unsuitable for percutaneous treatment with implantation of the available study stents.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: BioMime™ Sirolimus-Eluting Coronary Stent System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioMime™<br>BioMime™ DES | Device: Sirolimus Eluting Coronary Stent System (Biomime)<br>* Coronary Artey PTCA<br>* Other names: Biomime Sirolimus Eluting Stent System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE at 30 days clinical F/U | Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic Binary restenosis at 8-months F/U | Occurrence of Major Adverse Cardiac Events (MACE) defined as cardiac death, non-fatal acute myocardial infarction, and need for repeat target-lesion revascularization (by cardiac bypass graft or repeat percutaneous coronary intervention up to 24 months of follow-up. Angiographic binary restenosis at 8 months angiographic follow-up. | 8-months post implant |