Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent
NCT ID: NCT01135225
Last Updated: 2017-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
291 participants
INTERVENTIONAL
2010-07-31
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
NCT01665053
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)
NCT03875651
The EVOLVE China Clinical Trial
NCT01966159
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
NCT01148329
Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization
NCT01342822
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PROMUS(TM) Element(TM) Coronary Stent
PROMUS(TM) Element(TM) Everolimus-Eluting Coronary Stent System
PROMUS(TM) Element (TM) Stent System
The PROMUS Element Everolimus-Eluting Coronary Stent System is a device/drug combination product composed of two components: a device (coronary stent system) and a drug product (a formulation of everolimus contained in a polymer coating.
Evolution Coronary Stent A
Evolution Everolimus-Eluting Monorail Coronary Stent System
Evolution Stent System
The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).
Evolution Coronary Stent B
Evolution Everolimus-Eluting Monorail Coronary Stent System
Evolution Stent System
The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PROMUS(TM) Element (TM) Stent System
The PROMUS Element Everolimus-Eluting Coronary Stent System is a device/drug combination product composed of two components: a device (coronary stent system) and a drug product (a formulation of everolimus contained in a polymer coating.
Evolution Stent System
The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
* Patient is eligible for percutaneous coronary intervention (PCI)
* Patient has symptomatic coronary artery disease or documented silent ischemia
* Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
* Patient has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment
* Patient is willing to comply with all protocol-required follow-up evaluations
* Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤3.5 mm.
* Target lesion length must be ≤ 28 mm (by visual estimate)
* Target lesion must have visually estimated stenosis ≥50% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow \>1.
* Target lesion must be successfully pre-dilatated.
Exclusion Criteria
* Patient with unstable angina or recent MI (within 72 hours) must have CK/CK-MB or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:
1. If CK MB \>2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
2. If CK Total \>2× ULN, either CK-MB or troponin must be drawn and the patient is excluded if either CK-MB or troponin is abnormal.
3. If neither CK Total or CK MB is drawn but troponin is, the patient is excluded if:
* Troponin \>1× ULN and the patient has at least one of the following:
* Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\])
* Development of pathological Q waves in the ECG; or;
* Patient has received an organ transplant or is on a waiting list for an organ transplant
* Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
* Patient is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded ) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
* Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome
* Patient has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
* Patient has a white blood cell (WBC) count \<3,000 cells/mm3
* Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
* Patient is on dialysis or has known renal insufficiency (e.g. serum creatinine level \>2.0 mg/dL)
* Patient has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy, or will refuse transfusions
* Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
* Target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
* Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
* Non-target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure Note: 1 lesion in a non-target vessel may be treated during the index procedure prior to the treatment of the target (study) lesion. The treatment of lesion(s) in non-target vessels more than 24 hours prior to the procedure does not preclude the treatment of an additional non-target lesion during the index procedure. For example, a patient could have an RCA lesion treated 7 days prior to the index procedure and then have a non-target lesion in the LCx and a target lesion in the LAD treated during the index procedure.
* Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
* Planned PCI or CABG after the index procedure
* Patient previously treated at any time with coronary intravascular brachytherapy
* Patient has a known allergy to the trial stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
* Patient has one of the following.
* Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
* Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.
* Planned procedure that may cause non-compliance with the protocol or confound data interpretation
* Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
* Patient intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
* Patient with known intention to procreate within 12 months after the index procedure. (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
* Patient is a woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential.)
* Patient has more than 1 target lesion and 1 non-target lesion that will be treated during the index procedure
* Target lesion meets any of the following criteria.
* Left main location
* Located within 5 mm of the origin of the left anterior descending (LAD), left circumflex (LCX) or RCA by visual estimate
* Located within a saphenous vein graft or an arterial graft
* Will be accessed via a saphenous vein graft or arterial graft
* Involves a side branch ≥2.0 mm in diameter by visual estimate
* Involves a side branch \<2.0 mm in diameter by visual estimate which requires treatment
* TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
* Excessive tortuosity proximal to or within the lesion
* Excessive angulation proximal to or within the lesion
* Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
* Restenotic from previous intervention
* Thrombus, or possible thrombus, present in the target vessel
* Target lesion cannot be covered by a single study stent
* Patient has unprotected left main coronary artery disease (\>50% diameter stenosis)
* Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
* Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure may be required
* Non-target lesion to be treated during the index procedure meets any of the following criteria.
* Located within the target vessel
* Located within a bypass graft (venous or arterial)
* Left main location
* Chronic total occlusion
* Involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
* Requires additional unplanned stents
* Treatment not deemed a clinical angiographic success
* Treatment not completed prior to treatment of target lesion
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ian Meredith, Prof
Role: PRINCIPAL_INVESTIGATOR
Monash Medical Centre
Stefan Verheye, Dr
Role: PRINCIPAL_INVESTIGATOR
AZ Middelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Prince Charles Hospital
Chermside, , Australia
Monash Medical Centre
Clayton, , Australia
St. Vincent's Hospital (Melbourne)
Fitzroy, , Australia
Fremantle Hospital
Fremantle, , Australia
Academisch Ziekenhuis Middelheim
Antwerp, , Belgium
Ziekenhuis Oost Limburg
Genk, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, , Belgium
Skejby Sygehus
Aarhus, , Denmark
Rigshospitalet Thoraxkirurgisk Klinik RT
Copenhagen, , Denmark
Polyclinique Les Fleurs
Ollioules, , France
Hôpital Cochin
Paris, , France
Hôpital Rangueil
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Dunedin Hospital
Dunedin, , New Zealand
Middlemore Hospital
Otahuhu, , New Zealand
North Shore Hospital
Takapuna, , New Zealand
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy
Bydgoszcz, , Poland
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Falu lasarett
Falun, , Sweden
Uppsala Akademiska Hospital
Uppsala, , Sweden
Royal Victoria Hospital
Belfast, , United Kingdom
Papworth Hospital
Cambridge, , United Kingdom
Golden Jubilee National Hospital
Clydebank, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Meredith IT, Verheye S, Weissman NJ, Barragan P, Scott D, Valdes Chavarri M, West NE, Kelbaek H, Whitbourn R, Walters DL, Kubica J, Thuesen L, Masotti M, Banning A, Sjogren I, Stables RH, Allocco DJ, Dawkins KD. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013 Jul;9(3):308-15. doi: 10.4244/EIJV9I3A52.
Meredith IT, Verheye S, Weissman NJ, Barragan P, Scott D, Chavarri MV, West NE, Kelbaek H, Whitbourn R, Walters DL, Kubica J, Thuesen L, Masotti M, Banning A, Sjogren I, Stables RH, Allocco DJ, Dawkins KD. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013 May 22:20130416-02. Online ahead of print.
Meredith IT, Verheye S, Dubois CL, Dens J, Fajadet J, Carrie D, Walsh S, Oldroyd KG, Varenne O, El-Jack S, Moreno R, Joshi AA, Allocco DJ, Dawkins KD. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. J Am Coll Cardiol. 2012 Apr 10;59(15):1362-70. doi: 10.1016/j.jacc.2011.12.016. Epub 2012 Feb 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S2060
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.