This is an investigator initiated study to compare the safety and performance of the Promus Element Stent System in the treatment of Coronary lesion in Indian populatio
- Conditions
- Health Condition 1: null- Coronory Heart Disease
- Registration Number
- CTRI/2012/07/002808
- Lead Sponsor
- Institute of Cardio Vascular Diseases The Madras Medical Mission
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1000
CI1. Patients receiving PROMUS Element• stents.
Up to
3 Promus stents per patient
2 stents per artery
CI2.Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.
CI3.Patient is eligible for percutaneous coronary intervention (PCI)
CI4.Patient is willing to comply with all protocol-required follow-up evaluations.
CE1.Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, iron, thienopyridines, aspirin, contrast) that cannot be adequately pre-medicated.
CE2.Patient has any other serious medical illness (e.g., cancer, congestive heart failure - NYHA Class 3 and 4) that may reduce life expectancy to less than 12 months.
CE3.Patients with a mixture of other drug eluting stents
CE4.Pregnant and lactating females or females having positive pregnancy test (urine or serum)
CE5.Known/ Suspected case of Human Immunodeficiency Virus Infection
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite safety endpoint of Target Vessel Failure (TVF) rate <br/ ><br>â?¢Cardiac Death related to target vessel. <br/ ><br>â?¢Target Vessel Myocardial Infarction (TV-MI) <br/ ><br>â?¢Target Vessel Revascularization (TVR)Timepoint: Time point is 12 months post-index procedure
- Secondary Outcome Measures
Name Time Method