NCT01066650

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

The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,391 (actual)
• Sponsor: Foundation of Cardiovascular Research and Education Enschede · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Angina Pectoris
• Unstable Angina Pectoris
• Coronary Stenosis
• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)	Drug eluting Stent
DEVICE	Xience V (Everolimus-eluting stent)	Drug eluting stent

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-08-01
• Completion: 2012-09-01
• First posted: 2010-02-10
• Last updated: 2015-07-28

Locations

1 site across 1 country: Netherlands