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.
Study Type
OBSERVATIONAL
Enrollment
250
Columbia Asia Hospitals
Bangalore, Karnataka, India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bangalore, Karnataka, India
Narayana Hrudayalaya Institute of Medical Sciences
Bangalore, Karnataka, India
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
Time frame: 30 days
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)
Time frame: Until 12 months
Device related SAEs
Serious Adverse Events
Time frame: Until 12 months
Angioghraphic stent thrombosis
Acute (In hospital), Subacute (post procedure until 30 days) and Late (after 30 days until 12 months)
Time frame: 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.
Time frame: At 12 months
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