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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

Clinical Trials [853 Associated Clinical Trials listed on BioPortfolio]

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...

RESOLUTE International Registry: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population

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Comparison of Neointimal Coverage Between Zotarolimus Eluting Stent and Everolimus Eluting Stent

Stent thrombosis is an important issue in drug eluting stents. Incomplete endothelial coverage and neointimal coverage over strut after drug eluting stent (DES) implantation could be a pos...

PubMed Articles [12752 Associated PubMed Articles listed on BioPortfolio]

Safety and efficacy of the next generation Resolute Onyx zotarolimus-eluting stent: Primary outcome of the RESOLUTE ONYX core trial.

To assess the safety and efficacy of the novel Resolute (R-) Onyx drug-eluting stent (DES).

Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions.

Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus elut...

Impact of early (3 months) dual antiplatelet treatment interruption prior to renal transplantation in patients with second-generation DES on perioperative stent thrombosis and MACEs.

Early cessation of dual antiplatelet therapy (DAPT) is related to stent thrombosis (ST). The use of second-generation everolimus- and zotarolimus-eluting stents is associated with low restenosis rates...

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).

Comparison of Drug-Eluting Stent with Bare-Metal Stent Implantation in Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis.

This study aimed to perform a systematic review and meta-analysis of current evidence comparing the drug-eluting stent (DES) with the bare-metal stent (BMS) in the treatment of femoropopliteal artery ...

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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