Supralimus-Core(TM) Pharmacokinetic(PK) Study

Not Applicable

Completed

• Conditions: Health Condition 1: null- Coronary Artery Disease

• Registration Number: CTRI/2009/091/000426
• Lead Sponsor: Sahajanand Medical Technologies Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Age grater than or equal to18 years.

2. Eligible for percutaneous coronary intervention (PCI).

3. Acceptable candidate for CABG.

4. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.

5. The target lesion is a single de novo coronary artery lesion with grater than or equal to 50% and less than 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.

6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.

7. The target lesion must be grater than or equal to 33 mm in length by visual estimate.

8. The target reference vessel diameter must be grater than or equal to 2.25 mm and less than or equal to 4.0 mm.

9. Patient or patients legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as notified / approved by the Institutional Review Board/Ethics Committee of the clinical site.

Exclusion Criteria

1. Female of childbearing potential.

2. Documented left ventricular ejection fraction (LVEF) less than or equal to 25%.

3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure

4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix(R), Ceruvin) or ticlopidine (Ticlid(R)), heparin, sirolimus, stainless steel, contrast agent (that cannot be adequately pre-medicated).

5. A platelet count less than 100,000 cells/mm3 or grater than 700,000 cells/mm3 or a WBC less then 3,000 cells/mm3.

6. Acute or chronic renal dysfunction (creatinine grater then 2.0mg/dl or grater than150µmol/L).

7. Target vessel has evidence of thrombus.

8. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment.

9. Previous bare metal stenting (less than 1 year) anywhere within the target vessel.

10. Previous drug-eluting stenting anywhere within any epicardial vessel.

11. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)

12. Significant (grater than 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off.

13. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated.

14. Target lesion is located in or supplied by an arterial or venous bypass graft.

15. Ostial target lesion.

16. Patient is currently participating in an investigational drug or device study, including its follow-up period.

17. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind.

18. Within 48 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.

19. CVA within previous 6 months.

20. Unprotected Left Main (LM) coronary artery disease (stenosis grater than 50%).

21. In the investigators opinion, patient has a co-morbid condition(s) that could limit the patients ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.

22. Planned surgery within 48 days after the index procedure

23. Life expectancy less than 1 year

24. Any contraindication to blood sampling.

Study & Design

• Study Type: Interventional
• Study Design: Not specified