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The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente

2014-07-23 21:10:37 | BioPortfolio

Summary

The TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population. Patients will be blinded to the type of DES they will receive. The general practitioner of the patient will be requested not to disclose this information to the patient. Analysts who perform the data analyses will be blinded to the type DES used as well.

Description

Primary research questions

To investigate whether the clinical outcome following the randomized implantation of the Endeavor Resolute® versus XIENCE V® drug-eluting stent is similar, as assessed in a non-inferiority setting by comparing target-vessel failure (TVF) of both stents. We want to compare for both drug-eluting stents the combined endpoint of death, myocardial infarction or revascularization related to the target-vessel, as well as death or myocardial infarction that cannot be related to a significant flow obstruction in another vessel or to another cause. According to current literature, non-inferiority of Endeavor resolute ® and XIENCE V® is expected. But the non-inferiority of Endeavor resolute and XIENCE V® is not tested in a controlled randomized trial yet.

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

Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent), Xience V (Everolimus-eluting stent)

Location

Medisch Spectrum Twnete
Enschede
Overijssel
Netherlands
7513ER

Status

Recruiting

Source

Cardio Research Enschede BV

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:37-0400

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Zotarolimus and Everolimus-Eluting Stents ProsPectively Compared in Real World

The zotarolimus-eluting Endeavor Resolute stent is not inferior to the everolimus- eluting Xience V stent platform regarding a composite of cardiac death, myocardial infarction or target ...

ComparisiOn of Neointimal coVerage betwEen ZES and EES Using OCT at 3 Months

This study try to 1) evaluate the neointimal coverage and malapposition at 3 month after new zotarolimus eluting stent (Endeavor resolute) and everolimus eluting stent (Xience) implantatio...

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PubMed Articles [12697 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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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

A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.

The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.

Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.

Surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent.

Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.

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