To assess the safety andefficacy of BioMimeâ?¢ - Sirolimus Eluting Coronary Stent System in obstructive coronary artery disease

Phase 4

Completed

• Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

• Registration Number: CTRI/2016/11/007440
• Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Patient is an acceptable candidate for PTCA , Stenting or Emergent CABG

Symptomatic ischemic heart disease (CCS class 1-4, Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia.

TIMI flow grade >=2.

C.T.Oâ??s (chronic total occlusions) and bifurcation lesions may also be attempted.

Target lesion stenosis is >50% and <100%.

Target lesions are de novo

Target lesion <=35mm in length (by visual estimation) that can be treated by one single study stent (13 to 40mm in length)

Target lesion located in a major epicardial coronary vessel with reference of >= 2.5 -<= 3.5 mm in diameter (by visual estimation)

Target lesion which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1.5)

The patient and /or his legal representative have been informed of the nature of the study and agree to its provision s and have provided a written informed consent.

Exclusion Criteria

Women of childbearing potential

Impaired renal function (creatinine >2.0 mg/dl or 180 µ mol/l)

Any patient who has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cell/mm3 , or documented suspected liver disease (including laboratory evidence of Hepatitis.)

Recipient of an organ (Heart, Kidney, Lung) transplant.

History of CVA or TIA within the last 3 months.

Patient with a concomitant disease having a life expectancy of less than 12 months.

Known allergies or contraindications to mTOR inhibitor class of drugs (Sirolimus), Aspirin, Clopidogrel Bisulphate

Any significant medical condition which in the investigators opinion may interfere with the patients optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding.

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.

Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including thrombocytopenia, neutropenia or leucopenia

Patients with Cardiogenic Shock.

Angiographic Exclusion Criteria:

Left main coronary artery disease with >=50% stenosis.

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.)

Left Ventricular Ejection Fraction <= 30%

Saphenous Vein Graft Interventions (S.V.Gâ??s)

Patients presenting with an ongoing Acute Myocardial Infarction (AMI)

Patients having undergone a PCI within 48 hours of an AMI episode.

Study & Design

• Study Type: PMS
• Study Design: Not specified