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)

Completed

• Conditions: arteriosclerose; hardening of the arteries; 10011082; 10007593; 10003216

• Registration Number: NL-OMON39562
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1788

Inclusion Criteria

Minimum age of 18 years * Coronary artery disease and lesion(s) eligable 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: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Target vessel failure (TVF) at 12 months<br /><br>Components of the primary endpoint in hierarchical order:<br /><br>o Cardiac death. All deaths are considered cardiac, unless an unequivocal<br /><br>non-cardiac cause can be established.<br /><br>o Target vessel related MI that is Q-wave or non-Q-wave myocardial infarction<br /><br>that can be related to the target vessel or cannot be related to another vessel.<br /><br>o Clinically driven repeated target vessel revascularization by means of CABG<br /><br>or PCI</p><br>