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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Coronary Stenosis, Coronary Restenosis

Intervention / Treatment
-----------------
* Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)
* Device: Xience V (Everolimus-eluting stent)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endeavor Resolute<br> | Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)<br>* Drug eluting Stent<br>* Other names: Endeavor Resolute stent;|
| Active Comparator: Xience V<br> | Device: Xience V (Everolimus-eluting stent)<br>* Drug eluting stent<br>* Other names: Xience V drug eluting stent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing target-vessel failure (TVF) of both stents |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TWENTE, randomized study, stent, coronary stent, drug-eluting stent, Zotarolimus, Everolimus, Xience V, Endeavor Resolute, head to head comparison, real world patients, target vessel failure, investigator initiated study, coronary artery disease, coronary arteries, atherosclerosis, non inferiority