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

Coronary Artery Disease Clinical Trial

— DUTCH PEERS  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331707
• Other study ID #: DUTCH PEERS
• Secondary ID: NTR2413
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2011
• Last updated: July 27, 2015
• Start date: November 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Cardio Research Enschede BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1811
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Resolute Integrity (Zotarolimus-eluting stent)
Third generation drug-eluting stent
• Promus Element (Everolimus-eluting stent)
Third generation drug-eluting stent

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Hospital Rijnstate	Arnhem
Netherlands	Scheper Hospital	Emmen
Netherlands	Thoraxcentrum Twente	Enschede

Sponsors (1)

Lead Sponsor	Collaborator
Cardio Research Enschede BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization		1 year	Yes