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Trial record 2 of 45 for:    Promus Element

DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity (DUTCHPEERS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clemens von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:
NCT02175706
First received: November 27, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Angina Pectoris
Unstable Angina Pectoris
Acute Coronary Syndrome
Coronary Stenosis
Coronary Restenosis
Device: Resolute Integrity®
Device: Promus Element®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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).

Resource links provided by NLM:


Further study details as provided by Thorax Centrum Twente:

Primary Outcome Measures:
  • Target-vessel failure (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Components of the primary endpoint in hierarchical order:

    1. Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established;
    2. Target vessel related MI that is Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel;
    3. Clinically driven repeated target vessel revascularization by means of CABG or PCI.


Secondary Outcome Measures:
  • Death at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ] [ Designated as safety issue: Yes ]
    Death distinguished into: cardiac, vascular, other causes, all-cause mortality

  • Myocardial infarction at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ] [ Designated as safety issue: Yes ]
    Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction

  • Revascularization at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ] [ Designated as safety issue: No ]
    Target-vessel revascularization distinguished into PCI or CABG

  • Stent thrombosis at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ] [ Designated as safety issue: Yes ]
    Stent thrombosis was distinguished into definite, probable and possible according to the Academic Research Consortium (ARC) definition.


Other Outcome Measures:
  • Longitudinal stent deformation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Identification of deformation of a stent in the longitudinal axis during coronary angiographic assessment.


Enrollment: 1811
Study Start Date: November 2010
Estimated Study Completion Date: May 2017
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Resolute Integrity®
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.
Device: Resolute Integrity®
Biolinx-zotarolimus coating on a chobalt-cromium alloy stent platform that has a novel sinusoidal design.
Other Name: Resolute Integrity® drug eluting stent
Active Comparator: Promus Element®

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.

Device: Promus Element®
fluoropolymer-everolimus coating on a novel stent platform made from a platinum-chromium alloy
Other Name: Promus Element® drug eluting stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02175706

Locations
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
Scheper Ziekenhuis
Emmen, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Sponsors and Collaborators
Thorax Centrum Twente
Investigators
Principal Investigator: Clemens von Birgelen, MD,PhD,Prof Thorax Centrum Twente
  More Information

No publications provided

Responsible Party: Clemens von Birgelen, Professor, Thorax Centrum Twente
ClinicalTrials.gov Identifier: NCT02175706     History of Changes
Other Study ID Numbers: 1.6
Study First Received: November 27, 2013
Last Updated: June 24, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Angina, Unstable
Coronary Artery Disease
Coronary Disease
Coronary Restenosis
Coronary Stenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Heart Diseases
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014