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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066650
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Active Comparator: Endeavor Resolute Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)
Drug eluting Stent
Other Name: Endeavor Resolute stent

Active Comparator: Xience V Device: Xience V (Everolimus-eluting stent)
Drug eluting stent
Other Name: Xience V drug eluting stent

Primary Outcome Measures :
  1. comparing target-vessel failure (TVF) of both stents [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066650

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Medisch Spectrum Twnete
Enschede, Overijssel, Netherlands, 7513ER
Sponsors and Collaborators
Cardio Research Enschede BV
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Principal Investigator: C. von Birgelen, MD,PhD,Prof Thorax Centrum Twente

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: prof. C. von Birgelen, Professor Clemens von Birgelen, Thorax Centrum Twente Identifier: NCT01066650    
Other Study ID Numbers: TWENTE I
MST/Twente/001 ( Registry Identifier: Dutch trial registry /Nederlands trial register NTR1256 )
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by prof. C. von Birgelen, Thorax Centrum Twente:
randomized study
coronary stent
drug-eluting stent
Xience V
Endeavor Resolute
head to head comparison
real world patients
target vessel failure
investigator initiated study
coronary artery disease
coronary arteries
non inferiority
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Unstable
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents