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Clinical Trials/NCT01507519
NCT01507519CompletedNot Applicable

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.

Meril Life Sciences Pvt. Ltd.1 site in 1 country30 target enrollmentStarted: April 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
MACE at 30 days clinical F/U
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

BioMime™

Experimental

BioMime™ DES

Intervention: Sirolimus Eluting Coronary Stent System (Biomime) (Device)

Outcomes

Primary Outcomes

MACE at 30 days clinical F/U

Time Frame: 30 days

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 Outcomes

  • Angiographic Binary restenosis at 8-months F/U(8-months post implant)

Investigators

Sponsor
Meril Life Sciences Pvt. Ltd.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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