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SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent

2014-07-23 21:14:15 | BioPortfolio

Summary

The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.

Description

Series III Run-In is a prospective, multi-center, randomized, single-blind (patient-blind), non-inferiority trial to be conducted at approx. 35 interventional cardiology centers in India, Brazil, Argentina, Thailand and Saudi Aurabia. A total of 360 will be randomized on a 2:1 basis to either the Supralimus® (sirolimus-eluting) stent or the Xience V™ (everolimus-eluting) stent.

In selected sites, IVUS will also be recorded in these patients (maximum of 60 IVUS patients in total), at baseline (post-procedure) and at 9-month follow-up.

All patients will be followed clinically for up to 5 years after stent implantation. Repeat angiography will be performed in all patients at 9 months after the index procedure.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Coronary Artery Disease

Intervention

Supralimus(R) Sirolimus-Eluting Coronary Stent System, Xience V™ Everolimus Eluting Coronary Stent

Location

Hospital Meridional
Vitaria
Espirito Santo
Brazil
29156-580

Status

Active, not recruiting

Source

Sahajanand Medical Technologies Pvt. Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:14:15-0400

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Medical and Biotech [MESH] Definitions

A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT.

Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.

Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.

A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.

Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.

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