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Supralimus-Core™ Pharmacokinetic (PK) Study

2014-07-23 21:09:06 | BioPortfolio

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.

Study Design

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

Conditions

Coronary Artery Disease

Intervention

Supralimus-Core™ Sirolimus eluting Coronary Stent

Location

Life Care Institute of Medical Science & research
Ahmedabad
Gujarat
India
380014

Status

Recruiting

Source

Sahajanand Medical Technologies Pvt. Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:06-0400

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