DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population (DUTCH PEERS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 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:
NCT01331707
First received: March 30, 2011
Last updated: July 25, 2012
Last verified: July 2012

March 30, 2011
July 25, 2012
November 2010
December 2012   (final data collection date for primary outcome measure)
Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01331707 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2)

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Angina Pectoris
  • Angina, Unstable
  • Myocardial Infarction
  • Coronary Artery Disease
  • Coronary Stenosis
  • Coronary Restenosis
  • Device: Resolute Integrity (Zotarolimus-eluting stent)
    Third generation drug-eluting stent
  • Device: Promus Element (Everolimus-eluting stent)
    Third generation drug-eluting stent
  • Active Comparator: Promus Element
    Intervention: Device: Promus Element (Everolimus-eluting stent)
  • Active Comparator: Resolute Integrity
    Intervention: Device: Resolute Integrity (Zotarolimus-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
1788
December 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Minimum age of 18 years;
  • Coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement;
  • Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent.

Exclusion Criteria:

  • Participation in another randomized drug or device study before reaching primary endpoint;
  • Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
  • Intolerance to a P2Y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined;
  • Known pregnancy;
  • Life expectancy of less than 1 year.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01331707
DUTCH PEERS, NTR2413
Yes
prof. C. von Birgelen, Thorax Centrum Twente
Cardio Research Enschede BV
Not Provided
Not Provided
Cardio Research Enschede BV
July 2012

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