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

This study has been completed.
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente Identifier:
First received: February 9, 2010
Last updated: July 27, 2015
Last verified: July 2015
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 Intervention 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

Study Type: Interventional
Study Design: 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

Further study details as provided by prof. C. von Birgelen, Thorax Centrum Twente:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1391
Study Start Date: June 2008
Study Completion Date: September 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01066650

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

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

Responsible Party: prof. C. von Birgelen, Professor Clemens von Birgelen, Thorax Centrum Twente Identifier: NCT01066650     History of Changes
Other Study ID Numbers: TWENTE I
MST/Twente/001 ( Registry Identifier: Dutch trial registry /Nederlands trial register NTR1256 )
Study First Received: February 9, 2010
Last Updated: July 27, 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:
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
Nervous System Diseases
Signs and Symptoms
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on September 21, 2017