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

Coronary Artery Disease Clinical Trial

— TWENTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066650
• Other study ID #: TWENTE I
• Secondary ID: MST/Twente/001
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2010
• Last updated: July 27, 2015
• Start date: June 2008
• Est. completion date: September 2012

Study information

• Verified date: July 2015
• Source: Cardio Research Enschede BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1391
• Est. completion date: September 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for PCI with DES implantation based on VVC/ESC guidelines and/or clinical decision of interventional cardiologist

• Age = 18 years and mentally capable to give an informed consent

• Signed informed consent

Exclusion Criteria:

• Patients with ST-elevation myocardial infarction (STEMI) or an ST- elevation myocardial infarction equivalent requiring primary PCI or rescue PCI

• Patients in whom the revascularization procedure is planned to be performed in a staged approach

• Renal failure requiring haemodialysis

• Patient is currently participating in an investigational drug or device study that has been not completed

• In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study

• Life expectancy less than 1 year

• Patients in whom during PCI there is no indication for DES use and/or if the operator chooses not to use a DES based on the clinical situation, the patient will be excluded.

• If the choice of DES is dictated by logistic reasons e.g. the required DES dimensions is provided by one manufacturer only.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Ischemia
• Unstable Angina Pectoris

Intervention

Device:
• Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)
Drug eluting Stent
• Xience V (Everolimus-eluting stent)
Drug eluting stent

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twnete	Enschede	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Cardio Research Enschede BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparing target-vessel failure (TVF) of both stents		1 year	Yes
Secondary	the efficacy, safety, clinical short- and long-term outcome, and the acute angiographic results of the implantation of two second-generation drug-eluting stents		1 year	Yes