Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Meril Life Sciences Pvt. Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient must be ≥18 years of age; 2. Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG; 3. Symptomatic ischemic heart disease (CCS class 1-4 , Braunwald class IB, IC, IIB, IIC,IIIB,IIIC) and/or objective evidence of myocardial ischemia; 4. TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2 ; 5. C.T.O's (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted; 6. Target lesion stenosis is \>50% and \<100% ; 7. Target lesions are de novo; 8. Target lesions ≤ 35mm in length (by visual estimation) that can be treated (covered) by one single study stent (13 to 40mm in length) 9. Target lesion located in a major epicardial coronary vessel with reference of ≥ 2.5 - ≤ 3.5mm in diameter (by visual estimation) 10. Target lesions which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1.5) 11. The patient and/or his legal representative has been informed of the nature of the study and agrees to its provisions and has provided a written informed consent.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) days | 30 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | Until 12 months | 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) |
| Device related SAEs | Until 12 months | Serious Adverse Events |
| Angioghraphic stent thrombosis | After 30 days until 12 months | Acute (In hospital), Subacute (post procedure until 30 days) and Late (after 30 days until 12 months) |
| Angiographic/Device success, Procedural Success, Clinically justified Target Lesion Revascularization | At 12 months | 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. |
Countries
India
Outcome results
None listed