Supralimus-Core™ Pharmacokinetic (PK) Study

This study has been completed.
Sponsor:
Information provided by:
Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01121744
First received: May 10, 2010
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: Supralimus-Core™ Sirolimus eluting Coronary Stent

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

Resource links provided by NLM:


Further study details as provided by Sahajanand Medical Technologies Pvt. Ltd.:

Primary Outcome Measures:
  • Cmax, Tmax, AUC24h, AUClast, AUC∞, λz, t½term, CL [ Time Frame: Up to 48 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Adverse Cardiac Event (MACE) [ Time Frame: Up to 48 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Drug Eluting Stent (DES)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121744

Locations
India
Life Care Institute of Medical Science & research
Ahmedabad, Gujarat, India, 380014
Baroda Heart Institute & Research Center
Baroda, Gujarat, India, 390007
Shree B. D. Mahavir Heart Institute
Surat, Gujarat, India, 395001
Bankers Heart Institute
Vadodara, Gujarat, India, 390015
Sponsors and Collaborators
Sahajanand Medical Technologies Pvt. Ltd.
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Atul Abhyankar, Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01121744     History of Changes
Other Study ID Numbers: SC001:V.1.0:Dated 12/12/2008.
Study First Received: May 10, 2010
Last Updated: July 3, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by Sahajanand Medical Technologies Pvt. Ltd.:
Coronary Artery Disease
Drug Eluting Stents (DES)
Pharmacokinetic (PK)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014