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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014