An Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.

Coronary Artery Disease Clinical Trial

— meriT-2  

Official title:

A Prospective Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406326
• Other study ID #: BIO1TR/MLS/100209
• Status: Completed
• First received: March 30, 2015
• Last updated: April 9, 2018
• Start date: August 27, 2009
• Est. completion date: December 27, 2016

Study information

• Verified date: April 2018
• Source: Meril Life Sciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 27, 2016
• Est. primary completion date: December 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
India	Columbia Asia Hospitals	Bangalore	Karnataka
India	Narayana Hrudayalaya Institute of Medical Sciences	Bangalore	Karnataka
India	Sri Jayadeva Institute of Cardiovascular Sciences & Research	Bangalore	Karnataka
India	Advance Cardiac Centre	Chandigarh	Punjab
India	Apollo Group of Hospitals	Chennai	Tamil Nadu
India	Madras Medical Mission	Chennai	Tamil Nadu
India	Kovai Medical Centre and Hospitals Ltd	Coimbatore	Tamil Nadu
India	Hero DMC Heart Institute	Ludhiana	Punjab
India	Fortis/Wockhardt Hospital	Mumbai	Maharashtra
India	Fortis Escorts Heart Institute & Research Centre	New Delhi	Delhi
India	Poona Hopsital & Research Centre	Pune	Maharshtra

Sponsors (1)

Lead Sponsor	Collaborator
Meril Life Sciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE) days	composite of Death, MI (both Q-wave and Non Q-wave MI), Emergent CABG, or Clinically driven TLR (repeat PCI or CABG) and measured percentage wise	30 days
Secondary	Major Adverse Cardiac Events (MACE)	Major adverse cardiac events is defined as the aggregate of cardiac death, myocardial infarction (MI) attributed to target vessel, and any target lesion revascularization (TLR)	Until 12 months
Secondary	Device related SAEs	Serious Adverse Events	Until 12 months
Secondary	Angioghraphic stent thrombosis	Acute (In hospital), Subacute (post procedure until 30 days) and Late (after 30 days until 12 months)	After 30 days until 12 months
Secondary	Angiographic/Device success, Procedural Success, Clinically justified Target Lesion Revascularization	Quantitative Coronary Angiography derived vessel parameters In stent and 5 mm proximal and 5 mm distal from the edge of the stent (In-segment), Acute Gain (mm), Mild (%), Late loss (mm) and Binary Restenosis (%) rate, In stent MLD pre, post and 8 months angiographic follow up.	At 12 months

External Links

•   Study results at 12 month follow up