NCT01121744

Supralimus-Core™ Pharmacokinetic (PK) Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sahajanand Medical Technologies Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-11-01
• Completion: 2011-01-01
• First posted: 2010-05-12
• Last updated: 2012-07-04

Locations

4 sites across 1 country: India