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

NCT02175706 | Unknown DMC

• 1 other identifier: 1.6
• Study Type: interventional
• Target: 1,811
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Coronary Artery Disease; Angina Pectoris; Unstable Angina Pectoris; Acute Coronary Syndrome; Coronary Stenosis; Coronary Restenosis

Outcome Measures

Primary Outcomes (1)

• Target-vessel failure (TVF)

  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.

  1 year

Secondary Outcomes (4)

• Death at 1 and 2 year follow-up

  1 and 2 year

• Myocardial infarction at 1 and 2 year follow-up

  1 and 2 year

• Revascularization at 1 and 2 year follow-up

  1 and 2 year

• Stent thrombosis at 1 and 2 year follow-up

  1 and 2 year

Other Outcomes (1)

• Longitudinal stent deformation

  1 year

Study Arms (2)

Resolute Integrity®

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.

Device: Resolute Integrity®

Promus Element®

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.

Device: Promus Element®

Interventions

Resolute Integrity® DEVICE

Biolinx-zotarolimus coating on a chobalt-cromium alloy stent platform that has a novel sinusoidal design.

Also known as: Resolute Integrity® drug eluting stent

Resolute Integrity®

Promus Element® DEVICE

fluoropolymer-everolimus coating on a novel stent platform made from a platinum-chromium alloy

Also known as: Promus Element® drug eluting stent

Promus Element®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thorax Centrum Twente: lead

Study Sites (4)

Medisch Centrum Alkmaar

Alkmaar, Netherlands

Location

Ziekenhuis Rijnstate

Arnhem, Netherlands

Location

Scheper Ziekenhuis

Emmen, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Angina, Unstable; Acute Coronary Syndrome; Coronary Stenosis; Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemens von Birgelen, MD,PhD,Prof

  Thorax Centrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: June 26, 2014
• Study Start: November 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2017
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

NL (4)