Status:
COMPLETED
Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions
Lead Sponsor:
Meril Life Sciences Pvt. Ltd.
Collaborating Sponsors:
Lifecare Institute of Medical Sciences and Research Ahmedabad Gujarat India
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 intellige...
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 B...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01507519
Start Date
April 1 2009
End Date
March 1 2011
Last Update
April 5 2018
Active Locations (1)
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1
Life Care Institute of Medical Sciences & Research
Ahmedabad, Gujarat, India, 380024