A Observational Study to Evaluate Sirolimus Eluting Coronary Stent for the Treatment of the narrowing of the coronary artery, resulting in a poor blood flow to your heart muscle.

Phase 4

• Conditions: Health Condition 1: null- Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG with Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia.

• Registration Number: CTRI/2012/04/002612
• Lead Sponsor: Multimedics

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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1.The patient must be ï?³ 18 years of age;

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

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

4.C.T.Oâ??s (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted;

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

6.Target lesions are de novo;

7.Target lesions <=36mm in length (by visual estimation) that can be treated (covered) by one single Registry stent (8 to 40mm in length)

8.Target lesion located in a major epicardial coronary vessel with reference of >2.5 - <4.0mm in diameter (by visual estimation)

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

Exclusion Criteria

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 (Plavixï??), Heparin, Cobalt Chromium/Nickel,

contrast media;

8. Any significant medical condition which in the investigatorâ??s opinion may interfere

with the patientâ??s optimal participation in the Registry such as an active infection or

peptic ulcer or upper GI bleeding;

9. Currently participating in an investigational drug or another device Registry, or subject

to inclusion in another investigational drug or another device Registry during follow-

up.

10. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including

thrombocytopenia, neutropenia, or leukopenia

11. Patients with Cardiogenic Shock.

Study & Design

• Study Type: PMS
• Study Design: Not specified