Overview

This trial is active, not recruiting.

Conditions coronary artery disease, angina pectoris, unstable angina pectoris, acute coronary syndrome, coronary stenosis, coronary restenosis
Treatments resolute integrity®, promus element®
Phase phase 4
Sponsor Thorax Centrum Twente
Start date November 2010
End date May 2013
Trial size 1811 participants
Trial identifier NCT02175706, 1.6

Summary

Rationale:

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.

Objective:

To investigate whether the clinical outcome is similar after implantation of the Promus Element versus the Resolute Integrity stent (non-inferiority hypothesis).

Study design:

Multicenter, prospective, randomized single-blinded study.

Study population:

Patients who require percutaneous coronary interventions (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included.

Intervention:

In patients who are eligible for DES implantation, the type of DES implanted will be randomized (Resolute Integrity stent versus Promus Element stent). At the start of the study, both DES will also be used in routine clinical practice.

Main study endpoints:

The primary endpoint is the incidence of target vessel failure at one year follow-up. Target vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI, or clinically driven target vessel revascularization. Further secondary clinical and angiographic endpoints will be investigated, defined in accordance with suggestions of the Academic Research Consortium (ARC). Of note, the angiographic assessment is based on clinically indicated projections only and results in no additional x-ray exposure. There is no routine angiographic follow-up. If angiographic data are available in patients who undergo symptom-driven re-catheterization, we will analyze these data to get insight into the mechanisms of potential DES restenosis.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the routine clinical treatment. As a consequence, the risks of this trial do not exceed the risks of any routine PCI procedure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
The coating of Resolute Integrity consists of zotarolimus as antiproliferative agent and the BioLinx® polymer system. This polymer system consists of a blend of three different polymers: (1) the hydrophobic C10 polymer, which aids in the control of drug release; (2) the hydrophilic C19 polymer, which supports biocompatibility; and (3) polyvinyl pyrro-lidinone, which increases the initial drug burst and enhances the elution rate.
resolute integrity® Resolute Integrity® drug eluting stent
Biolinx-zotarolimus coating on a chobalt-cromium alloy stent platform that has a novel sinusoidal design.
(Active Comparator)
Promus Element utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation. Promus Element is composed of the Element platform, a thin fluoropolymer coating, and Everolimus.
promus element® Promus Element® drug eluting stent
fluoropolymer-everolimus coating on a novel stent platform made from a platinum-chromium alloy

Primary Outcomes

Measure
Target-vessel failure (TVF)
time frame: 1 year

Secondary Outcomes

Measure
Death at 1 and 2 year follow-up
time frame: 1 and 2 year
Myocardial infarction at 1 and 2 year follow-up
time frame: 1 and 2 year
Revascularization at 1 and 2 year follow-up
time frame: 1 and 2 year
Stent thrombosis at 1 and 2 year follow-up
time frame: 1 and 2 year

Eligibility Criteria

Male or female participants at least 18 years old.

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 aspirin, clopidogrel or ticlopidin, heparin, or components of the two DES examined; - Known pregnancy; - Life expectancy of less than 1 year.

Additional Information

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).
Principal investigator Clemens von Birgelen, MD,PhD,Prof
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Thorax Centrum Twente.