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

Foundation of Cardiovascular Research and Education Enschede

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Coronary Restenosis

Unstable Angina Pectoris

Angina Pectoris

Coronary Stenosis

Treatments

Device: Xience V (Everolimus-eluting stent)

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01066650

MST/Twente/001 (Registry Identifier)

TWENTE I

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,391 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.