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TAXUS Libertē Post Approval Study

2014-08-27 03:18:34 | BioPortfolio

Summary

The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen.

This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study).

Description

The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. This is a consecutively-enrolled study with patient follow-up through 5 years post index procedure. This study also will contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study). To facilitate this patient data contribution, patients will be assigned to patient groups based upon their co-morbidities and stented lesions identified post index procedure.

All enrolled patients who have been treated with the TAXUS Liberté Stent will be assigned to 12 months of open-label prasugrel treatment and aspirin. Upon completion of the open-label period, patients who are clear of events at 12 months post index procedure will be randomized 1:1 to either a placebo or prasugrel for an additional 18 months of treatment, followed by a 3-month period of observation. After this 3 month observation period, patients may receive open-label thienopyridine of choice at the discretion of the treating physician for the remainder of the study. All patients will receive aspirin therapy throughout the course of the study.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Coronary Artery Disease

Intervention

TAXUS Liberté Paclitaxel-Eluting Coronary Stent, prasugrel, placebo, aspirin

Location

Baptist Medical Center Princeton
Birmingham
Alabama
United States
35211

Status

Recruiting

Source

Boston Scientific Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:34-0400

Clinical Trials [3028 Associated Clinical Trials listed on BioPortfolio]

Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

The utilization of paclitaxel-eluting coronary stents in small vessel diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follo...

TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions

TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control. The c...

Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions

TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stentin...

A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels

TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent versus a...

Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™

The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug elut...

PubMed Articles [3243 Associated PubMed Articles listed on BioPortfolio]

Long-term clinical observations for a biofunctionalized stent: Yet to deliver their theoretical benefits.

Endothelial progenitor cells (EPCs) may allow accelerated and functional endothelialization of stents, theoretically reducing late stent complications as well reducing the duration of DAPT. In a pilot...

The relationship between timing of prasugrel pretreatment and in-stent thrombus immediately after percutaneous coronary intervention for acute coronary syndrome: an optical coherence tomography study.

The optimal timing of pretreatment with prasugrel in percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) is unclear. We used optical coherence tomography (OCT) to compare in-ste...

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.

The optimal treatment of in-stent restenosis (ISR) remains unknown. This study evaluates the efficacy and safety of a paclitaxel coated balloon compared to a 2nd generation sirolimus eluting stent in ...

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.

Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial.

This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs).

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 piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.

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

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.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

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