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

July 27, 2015 updated by: prof. C. von Birgelen, Foundation of Cardiovascular Research and Education Enschede

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1391

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7513ER
        • Medisch Spectrum Twnete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation of Cardiovascular Research and Education Enschede

Investigators

  • Principal Investigator: C. von Birgelen, MD,PhD,Prof, Thorax Centrum Twente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWENTE I
  • MST/Twente/001 (Registry Identifier: Dutch trial registry /Nederlands trial register NTR1256)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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