Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions (meriT-1)

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.

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Sirolimus Eluting Coronary Stent System (Biomime)

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)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380024
      • Life Care Institute of Medical Sciences & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioMime™; BioMime™ DES	Device: Sirolimus Eluting Coronary Stent System (Biomime); Coronary Artey PTCA; 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

Collaborators and Investigators

• Sponsor: Meril Life Sciences Pvt. Ltd.
• Collaborators: Lifecare Institute of Medical Sciences and Research Ahmedabad Gujarat India
• Investigators: Principal Investigator: SAMEER DANI, MD;DM(Card.), Life Care Institute of Medical Sciences & Research Centre

Publications and helpful links

Helpful Links

• First in man study

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 10, 2012
• First Posted (Estimate): January 11, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: BIOFIM/MLS/100209