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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Device related SAEs |
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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria:
Angiographic Exclusion criteria:
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The study population will consist of 250 patients with an obstructive coronary artery disease with few exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Ashok Seth, FRCP, FACC,FMRCP, MBBS | Fortis Escorts Heart Institute & Research Centre | Principal Investigator |
| Dr. Ajit Mullasari, DNB, DM, MD, MBBS | Madras Medical Mission | Principal Investigator |
| Dr. Rohit M Kumar, DM, MD, MBBS | Advance Cardiac Centre | Principal Investigator |
| Dr. Samuel K Mathew, DM, MD, MBBS | Apollo Group of Hospitals | Principal Investigator |
| Dr. G S Wander, DM, MD, MBBS | Hero DMC Heart Institute | Principal Investigator |
| Dr. C. N. Manjunath, DM, MD, MBBS | Sri Jayadeva Institute of Cardiovascular Sciences & Research | Principal Investigator |
| Dr. Thomas Alexander, FCSI, FICC, FACC, DM, MD, MBBS | Kovai Medical Centre and Hospitals Ltd | Principal Investigator |
| Dr. Suresh Vijan, MRCP, MD, MBBS | Fortis/Wockhardt Hospital | Principal Investigator |
| Dr. Suhas Hardas, DM, MD, MBBS | Poona Hopsital & Research Centre |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Asia Hospitals | Bangalore | Karnataka | 560055 | India | ||
| Sri Jayadeva Institute of Cardiovascular Sciences & Research |
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| Label | URL |
|---|---|
| Study results at 12 month follow up | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Serious Adverse Events |
| Until 12 months |
| 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 |
| 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 |
| Principal Investigator |
| Dr. Sunitha Abraham, DNB, MD, MBBS | Narayana Hrudayalaya Institute of Medical Sciences | Principal Investigator |
| Dr. Prabhakar Shetty, FACC, DM, MD, MBBS | Columbia Asia Hospitals | Principal Investigator |
| Bangalore |
| Karnataka |
| 560069 |
| India |
| Narayana Hrudayalaya Institute of Medical Sciences | Bangalore | Karnataka | 560099 | India |
| Fortis/Wockhardt Hospital | Mumbai | Maharashtra | 400011 | India |
| Poona Hopsital & Research Centre | Pune | Maharshtra | 411030 | India |
| Fortis Escorts Heart Institute & Research Centre | New Delhi | National Capital Territory of Delhi | 110025 | India |
| Advance Cardiac Centre | Chandigarh | Punjab | 160012 | India |
| Hero DMC Heart Institute | Ludhiana | Punjab | 141001 | India |
| Madras Medical Mission | Chennai | Tamil Nadu | 600037 | India |
| Apollo Group of Hospitals | Chennai | Tamil Nadu | 600081 | India |
| Kovai Medical Centre and Hospitals Ltd | Coimbatore | Tamil Nadu | 641014 | India |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |