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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 1,391
- Locations
- 1
- Primary Endpoint
- comparing target-vessel failure (TVF) of both stents
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Endeavor Resolute
Intervention: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) (Device)
Xience V
Intervention: Xience V (Everolimus-eluting stent) (Device)
Outcomes
Primary Outcomes
comparing target-vessel failure (TVF) of both stents
Time Frame: 1 year
Secondary Outcomes
- 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)
Investigators
prof. C. von Birgelen
Professor Clemens von Birgelen
Thorax Centrum Twente