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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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
Cmax, Tmax, AUC24h, AUClast, AUC∞, λz, t½term, CL
Time frame: Up to 48 days
Major Adverse Cardiac Event (MACE)
Time frame: Up to 48 days
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