Clinical trial NCT02406326: An Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.
Official title: A Prospective Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Meril Life Sciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 250 patients with an obstructive coronary artery disease with few exclusion criteria.

Brief summary: This is a multi centre, prospective trial. 250 patients will be enrolled in the study.(10 patients per centre involving approximately 25 centres). Patients will be followed up clinically for twelve months post-procedure at 1 month, 6 months \& 12 months. All patients will have a repeat angiography at 8 months. Clinical follow-up will be maintained for years 3 \& 5 post-implant.

Detailed description: This is a multi centre, prospective observational study. 250 patients will be enrolled in the study. 10 patients per centre involving approximately 25 centres. All the patients will be followed for twelve months post-procedure. All patients will have a repeat angiography assessment at 8 months. An additional clinical follow-up will be maintained for years 3 \& 5 post-implant.

Approximately 250 patients with obstructive coronary artery disease with a vessel size between ≥2.5 to ≤3.5 mm in diameter by visual estimate and who meet all eligibility criteria will be treated with the Sirolimus Eluting Stent.

It is anticipated that the total length of the study will be 16 months: 4 months to complete patient enrollment and 12 months for angiographic follow-up.

Eligibility criteria: Inclusion Criteria:

1. The patient must be ≥18 years of age;
2. Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG;
3. Symptomatic ischemic heart disease (CCS class 1-4 , Braunwald class IB, IC, IIB, IIC,IIIB,IIIC) and/or objective evidence of myocardial ischemia;
4. TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2 ;
5. C.T.O's (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted;
6. Target lesion stenosis is \>50% and \<100% ;
7. Target lesions are de novo;
8. Target lesions ≤ 35mm in length (by visual estimation) that can be treated (covered) by one single study stent (13 to 40mm in length)
9. Target lesion located in a major epicardial coronary vessel with reference of ≥ 2.5 - ≤ 3.5mm in diameter (by visual estimation)
10. Target lesions which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1.5)
11. The patient and/or his legal representative has been informed of the nature of the study and agrees to its provisions and has provided a written informed consent.

Exclusion Criteria:

General exclusion criteria:

1. Women of childbearing potential;
2. Impaired renal function (creatinine \> 2.0 mg/dl or 180 μmol/l);
3. Any patient who has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of Hepatitis;
4. Recipient of an organ (Heart, Kidney, Lung or Liver) transplant;
5. History of CVA or TIA within the last 3 months
6. Patient with a concomitant disease having a life expectancy of less than 12 months;
7. Known allergies or contraindication to mTOR inhibitor class of drugs (Sirolimus), Aspirin, Clopidogrel Bisulphate (Plavix®), Heparin, Cobalt Chromium/Nickel, contrast media;
8. Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding;
9. Currently participating in an investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow-up.
10. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including thrombocytopenia, neutropenia, or leukopenia
11. Patients with Cardiogenic Shock.

Angiographic Exclusion criteria:

1. Left main coronary artery disease with ≥ 50% stenosis,
2. Angiographic evidence of thrombus (thrombus larger than half the diameter of the vessel and/or requiring other adjunctive interventions such as Angiojet, Exciser, Thrombolysis, etc.),
3. Left Ventricular Ejection Fraction ≤30 %,
4. Saphenous Vein Graft Interventions, (S.V.G's)
5. Patients presenting with an ongoing Acute Myocardial Infarction (AMI),
6. Patients having undergone a PCI within 48 hours of an AMI episode.

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE) days
timeFrame: 30 days
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Until 12 months
measure: Device related SAEs
timeFrame: Until 12 months
measure: Angioghraphic stent thrombosis
timeFrame: After 30 days until 12 months
measure: Angiographic/Device success, Procedural Success, Clinically justified Target Lesion Revascularization
timeFrame: At 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute & Research Centre
state: Delhi
city: Bangalore
country: India
facility: Columbia Asia Hospitals
state: Karnataka
city: Bangalore
country: India
facility: Sri Jayadeva Institute of Cardiovascular Sciences & Research
state: Karnataka
city: Bangalore
country: India
facility: Narayana Hrudayalaya Institute of Medical Sciences
state: Karnataka
city: Mumbai
country: India
facility: Fortis/Wockhardt Hospital
state: Maharashtra
city: Pune
country: India
facility: Poona Hopsital & Research Centre
state: Maharshtra
city: Chandigarh
country: India
facility: Advance Cardiac Centre
state: Punjab
city: Ludhiana
country: India
facility: Hero DMC Heart Institute
state: Punjab
city: Chennai
country: India
facility: Madras Medical Mission
state: Tamil Nadu
city: Chennai
country: India
facility: Apollo Group of Hospitals
state: Tamil Nadu
city: Coimbatore
country: India
facility: Kovai Medical Centre and Hospitals Ltd
state: Tamil Nadu
Study officials:
affiliation: Fortis Escorts Heart Institute & Research Centre
name: Dr. Ashok Seth, FRCP, FACC,FMRCP, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Madras Medical Mission
name: Dr. Ajit Mullasari, DNB, DM, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Advance Cardiac Centre
name: Dr. Rohit M Kumar, DM, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Group of Hospitals
name: Dr. Samuel K Mathew, DM, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Hero DMC Heart Institute
name: Dr. G S Wander, DM, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Sri Jayadeva Institute of Cardiovascular Sciences & Research
name: Dr. C. N. Manjunath, DM, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Kovai Medical Centre and Hospitals Ltd
name: Dr. Thomas Alexander, FCSI, FICC, FACC, DM, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Fortis/Wockhardt Hospital
name: Dr. Suresh Vijan, MRCP, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Poona Hopsital & Research Centre
name: Dr. Suhas Hardas, DM, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Narayana Hrudayalaya Institute of Medical Sciences
name: Dr. Sunitha Abraham, DNB, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia Asia Hospitals
name: Dr. Prabhakar Shetty, FACC, DM, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
References: