Supralimus-Core™ Pharmacokinetic (PK) Study

Coronary Artery Disease Clinical Trial

Official title:

Supralimus-Core™ Pharmacokinetic (PK) Study: Evaluation of Pharmacokinetic (PK) and Safety of the Supralimus-Core™ Sirolimus Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121744
• Other study ID #: SC001:V.1.0:Dated 12/12/2008.
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: July 3, 2012
• Start date: April 2010
• Est. completion date: January 2011

Study information

• Verified date: July 2012
• Source: Sahajanand Medical Technologies Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Patients with de novo native coronary artery lesions located in epicardial vessel who qualify for percutaneous coronary intervention will be included according to the inclusion and exclusion criteria specified below:

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.

5. The target lesion is a single de novo coronary artery lesion with = 50% and < 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 = 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.

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
India	Life Care Institute of Medical Science & research	Ahmedabad	Gujarat
India	Baroda Heart Institute & Research Center	Baroda	Gujarat
India	Shree B. D. Mahavir Heart Institute	Surat	Gujarat
India	Bankers Heart Institute	Vadodara	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Pvt. Ltd.

Country where clinical trial is conducted

India, 

References & Publications (1)

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® pharmacokinetic study. Indian Heart J. 2012 May-Jun;6 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax, Tmax, AUC24h, AUClast, AUC8, ?z, t½term, CL		Up to 48 days	No
Secondary	Major Adverse Cardiac Event (MACE)		Up to 48 days	Yes