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

Sponsor

Foundation of Cardiovascular Research and Education Enschede (Other)

Overall Status

Completed

CT.gov ID

NCT01066650

Collaborator

(none)

1,391

Enrollment

Location

Arms

Duration (Months)

27.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Angina Pectoris Unstable Angina Pectoris Coronary Stenosis Coronary Restenosis	Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) Device: Xience V (Everolimus-eluting stent)	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1391 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Endeavor Resolute	Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) Drug eluting Stent Other Names: Endeavor Resolute stent
Active Comparator: Xience V	Device: Xience V (Everolimus-eluting stent) Drug eluting stent Other Names: Xience V drug eluting stent

Arm

Intervention/Treatment

Active Comparator: Endeavor Resolute

Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)

Drug eluting Stent

Other Names:

Endeavor Resolute stent

Active Comparator: Xience V

Device: Xience V (Everolimus-eluting stent)

Drug eluting stent

Other Names:

Xience V drug eluting stent

Outcome Measures

Primary Outcome Measures

comparing target-vessel failure (TVF) of both stents [1 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.