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SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

2014-07-23 21:48:25 | BioPortfolio

Summary

Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Description

The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.

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 Disease

Intervention

XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Location

Wilheminenspital der Stadt Wien
Vienna
Epsom
Austria
1160

Status

Active, not recruiting

Source

Abbott Vascular

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:25-0400

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SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

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PubMed Articles [2381 Associated PubMed Articles listed on BioPortfolio]

Everolimus drug-eluting stent performance in patients with long coronary lesions: The multicenter Longprime registry.

To assess the efficacy and safety of the Xience Prime everolimus-eluting stent (EES) in long coronary lesions in a real-world population.

Culotte stenting for coronary bifurcation lesions with 2nd and 3rd generation everolimus-eluting stents: the CELTIC Bifurcation Study.

The aim of this study was to provide contemporary outcome data for patients with de novo coronary disease and Medina 1,1,1 lesions who were treated with a culotte two-stent technique, and to compare t...

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It remains controversial whether coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) should be optimized to treat coronary artery disease in patients on chronic hemodialysi...

Angiographic and clinical performance of a paclitaxel coated balloon compared to a 2nd generation sirolimus eluting stent in patients with in-stent restenosis- the BIOLUX randomized controlled trial.

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Medical and Biotech [MESH] Definitions

Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL).

A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.

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