Health Condition 1: null- Coronory Heart Disease
Conditions
Interventions
Intervention1: The PROMUS Elementâ?¢ stent: Intervention - The PROMUS Elementâ?¢ stent is a stent with a drug/polymer coating. The coating comprises two layers. The inner layer consists of a polymer t
the outer layer is a polymer matrix that contains an active pharmaceutical ingredient.
PROMUS Elementâ?¢ comprises the following key components:
1. Everolimus
2. Two polymers
3. The Element stent com
Sponsors
Institute of Cardio Vascular Diseases The Madras Medical Mission
Dr Ajit Mullasari
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite safety endpoint of Target Vessel Failure (TVF) rate â?¢Cardiac Death related to target vessel. â?¢Target Vessel Myocardial Infarction (TV-MI) â?¢Target Vessel Revascularization (TVR)Timepoint: Time point is 12 months post-index procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Major Adverse Cardiac Events (MACE) which is the composite endpoint of cardiac death, all myocardial infarction, and TLRTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢All death or MI rateTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢All death rateTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢Cardiac death or MI rateTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢Cardiac death rateTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢Composite of all deaths, all MI, all revascularizationsTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢Composite of cardiac death or target vessel MITimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢MI (Q-wave and nonâ??Q-wave) rateTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢Non-cardiac death rateTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢Stent thrombosis rate (definite or probable by Academic Research Consortium [ARC] definitions)Timepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢Target Lesion Revascularization (TLR)Timepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢TVF rateTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure);â?¢TVR rateTimepoint: (Time point is 30, 180 days, year 1 and year 2 post index procedure) | — |
Countries
India
Contacts
Public ContactDr Ajit Mullasari MD
The Madras Medical Mission
Outcome results
None listed