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

Phase 4

Completed

• Conditions: Angina, Unstable; Coronary Stenosis; Coronary Restenosis; Angina Pectoris; Myocardial Infarction; Acute Coronary Syndrome; Coronary Artery Disease
• Interventions: Device: Resolute Integrity (Zotarolimus-eluting stent); Device: Promus Element (Everolimus-eluting stent)

• Registration Number: NCT01331707
• Lead Sponsor: Foundation of Cardiovascular Research and Education Enschede

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1811

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resolute Integrity	Resolute Integrity (Zotarolimus-eluting stent)	-
Promus Element	Promus Element (Everolimus-eluting stent)	-

Primary Outcome Measures

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

Trial Locations

Locations (4)

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Netherlands

Thoraxcentrum Twente; 🇳🇱 Enschede, Netherlands

Scheper Hospital; 🇳🇱 Emmen, Netherlands

Hospital Rijnstate; 🇳🇱 Arnhem, Netherlands