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

Sponsor

Foundation of Cardiovascular Research and Education Enschede (Other)

Overall Status

Completed

CT.gov ID

NCT01331707

Collaborator

(none)

1,811

Enrollment

Locations

Arms

Duration (Months)

452.8

Patients Per Site

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Angina Pectoris Angina, Unstable Myocardial Infarction Coronary Artery Disease Coronary Stenosis Coronary Restenosis	Device: Resolute Integrity (Zotarolimus-eluting stent) Device: Promus Element (Everolimus-eluting stent)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1811 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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)

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Promus Element	Device: Promus Element (Everolimus-eluting stent) Third generation drug-eluting stent
Active Comparator: Resolute Integrity	Device: Resolute Integrity (Zotarolimus-eluting stent) Third generation drug-eluting stent

Arm

Intervention/Treatment

Active Comparator: Promus Element

Device: Promus Element (Everolimus-eluting stent)

Third generation drug-eluting stent

Active Comparator: Resolute Integrity

Device: Resolute Integrity (Zotarolimus-eluting stent)

Third generation drug-eluting stent

Outcome Measures

Primary Outcome Measures

Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Medisch Centrum Alkmaar	Alkmaar	Netherlands
2	Hospital Rijnstate	Arnhem	Netherlands
3	Scheper Hospital	Emmen	Netherlands
4	Thoraxcentrum Twente	Enschede	Netherlands