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

This study has been completed.
Sponsor:
Collaborator:
Lifecare Institute of Medical Sciences and Research Ahmedabad Gujarat India
Information provided by (Responsible Party):
Meril Life Sciences Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01507519
First received: January 6, 2012
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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

Condition Intervention Phase
Coronary Artery Disease
Device: Sirolimus Eluting Coronary Stent System (Biomime)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The First-In_Man Safety and Performance Evaluation of the Biomime Sirolimus Eluting Stent System for the Treatment of Patients With Single, Discrete, De Novo, Non-Complex Coronary Lesions-The Biomime Pilot FiM Trial.

Resource links provided by NLM:


Further study details as provided by Meril Life Sciences Pvt. Ltd.:

Primary Outcome Measures:
  • MACE at 30 days clinical F/U [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Angiographic Binary restenosis at 8-months F/U [ Time Frame: 8-months post implant ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 30
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Sirolimus Eluting Coronary Stent System (Biomime)
    Coronary Artey PTCA
    Other Name: Biomime Sirolimus Eluting Stent System
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507519

Locations
India
Life Care Institute of Medical Sciences & Research
Ahmedabad, Gujarat, India, 380024
Sponsors and Collaborators
Meril Life Sciences Pvt. Ltd.
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
  More Information

No publications provided

Responsible Party: Meril Life Sciences Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01507519     History of Changes
Other Study ID Numbers: BIOFIM/MLS/100209
Study First Received: January 6, 2012
Last Updated: January 10, 2012
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014