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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Cardio Research Enschede BV.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:
NCT01066650
First received: February 9, 2010
Last updated: June 4, 2012
Last verified: June 2012

February 9, 2010
June 4, 2012
June 2008
August 2010   (final data collection date for primary outcome measure)
comparing target-vessel failure (TVF) of both stents [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01066650 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Angina Pectoris
  • Unstable Angina Pectoris
  • Coronary Stenosis
  • Coronary Restenosis
  • Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)
    Drug eluting Stent
    Other Name: Endeavor Resolute stent
  • Device: Xience V (Everolimus-eluting stent)
    Drug eluting stent
    Other Name: Xience V drug eluting stent
  • Active Comparator: Endeavor Resolute
    Intervention: Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)
  • Active Comparator: Xience V
    Intervention: Device: Xience V (Everolimus-eluting stent)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1380
September 2012
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01066650
TWENTE I, MST/Twente/001
Yes
prof. C. von Birgelen, Thorax Centrum Twente
Cardio Research Enschede BV
Not Provided
Principal Investigator: C. von Birgelen, MD,PhD,Prof Thorax Centrum Twente
Cardio Research Enschede BV
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP