Supralimus-Core™ Pharmacokinetic (PK) Study

NCT ID: NCT01121744

Last Updated: 2012-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-01-31

Brief Summary

The primary objective of this study is to evaluate the pharmacokinetic (PK) and safety associated with Supralimus-Core™ Sirolimus Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 to 3.5 mm in diameter.

Detailed Description

This is a multi-centric, interventional, non-randomized, open label, Uncontrolled, single group assignment, Pharmacokinetics study. Approximately 20 patients will be enrolled in the study. Patients will be followed for 48 days post-procedure.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Drug Eluting Stents (DES); Pharmacokinetic (PK)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Supralimus-Core™ Sirolimus eluting Coronary Stent

Supralimus-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Sirolimus Drug concentration is 1.4 µg/mm2.

Intervention Type: DEVICE

Other Intervention Names

Drug Eluting Stent (DES)

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 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.

Exclusion Criteria

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 ≤ 34 mm in length by visual estimate.

8. The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.

9. Patient or patient's 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.

1. Female of childbearing potential

2. Documented left ventricular ejection fraction (LVEF) ≤ 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®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, cobalt chromium, contrast agent (that cannot be adequately pre-medicated)

5. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3

6. Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/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 (>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 >50%)

21. In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahajanand Medical Technologies Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Sahajanand Medical Technologies Pvt. Ltd.

Locations

Life Care Institute of Medical Science & research

Ahmedabad, Gujarat, India

Shree B. D. Mahavir Heart Institute

Surat, Gujarat, India

Baroda Heart Institute & Research Center

Vadodara, Gujarat, India

Bankers Heart Institute

Vadodara, Gujarat, India

Countries

India

References

Thakkar AS, Abhyankar AD, Dani SI, Banker DN, Singh PI, Parmar SA, Mehta AA. Systemic exposure of sirolimus after coronary stent implantation in patients with de novo coronary lesions: Supralimus-Core(R) pharmacokinetic study. Indian Heart J. 2012 May-Jun;64(3):273-9. doi: 10.1016/S0019-4832(12)60086-8.

Reference Type: RESULT

PMID: 22664810 (View on PubMed)

Other Identifiers

SC001:V.1.0:Dated 12/12/2008.

Identifier Type: -

Identifier Source: org_study_id