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Coronary Artery DiseaseEvolveNCT01135225

Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent

A study testing PROMUS(TM) Element (TM) Stent System and Evolution Stent System in people with Coronary Artery Disease, run by Boston Scientific Corporation at 29 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
PROMUS(TM) Element (TM) Stent System and Evolution Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
291 participants
Where
29 sitesin 9 countries
Study dates
Jul 2010to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be at least 18 years of age
  • 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

Who cannot join

  • Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
  • 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:
  • If CK MB >2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
  • 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.
  • 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:
Show all 67Show fewer
  • 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;
  • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Patients with stable angina must have CK/CK-MB or troponin drawn prior to the index procedure. However, the results for these patients do not need to be available prior to the index procedure and there are no exclusion criteria based on these studies.
  • 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
  • Angiographic Inclusion criteria (Visual Estimate):
  • 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.
  • Angiographic Exclusion criteria (visual estimate):
  • 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

Trial locations and contacts

29 sites in 9 countries.

29 sites in 9 countries

United Kingdom5 sites

  • Royal Victoria Hospital

    Belfast, BT 12 6BA

  • Papworth Hospital

    Cambridge, CB3 8RE

  • Golden Jubilee National Hospital

    Clydebank, G81 4HX

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE

  • John Radcliffe Hospital

    Oxford, 0X3 9DU

Other trials in United Kingdom

Australia4 sites

  • The Prince Charles Hospital

    Chermside, QLD 4032

  • Monash Medical Centre

    Clayton, VIC 3168

  • St. Vincent's Hospital (Melbourne)

    Fitzroy, VIC 3065

  • Fremantle Hospital

    Fremantle, 6160

Other trials in Australia

Belgium4 sites

  • Academisch Ziekenhuis Middelheim

    Antwerp, 2020

  • Ziekenhuis Oost Limburg

    Genk, 3600

  • UZ Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire Sart Tilman Liège

    Liège, 4000

Other trials in Belgium

France4 sites

  • Polyclinique Les Fleurs

    Ollioules, 83190

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Rangueil

    Toulouse, 31059

  • Clinique Pasteur

    Toulouse, 31087

Other trials in France

Spain4 sites

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

New Zealand3 sites

  • Dunedin Hospital

    Dunedin, 9016

  • Middlemore Hospital

    Otahuhu, 1640

  • North Shore Hospital

    Takapuna, 0622

Other trials in New Zealand

Denmark2 sites

  • Skejby Sygehus

    Aarhus, 8200

  • Rigshospitalet Thoraxkirurgisk Klinik RT

    Copenhagen, 2100

Other trials in Denmark

Sweden2 sites

  • Falu lasarett

    Falun, 79182

  • Uppsala Akademiska Hospital

    Uppsala, 756 52

Other trials in Sweden

Poland1 site

  • Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

    Bydgoszcz, 85-094

Other trials in Poland

About this study

Official title: EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion

The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.

Being tested
PROMUS(TM) Element (TM) Stent System, Evolution Stent System
Keywords
Drug-eluting stent, Percutaneous coronary intervention, Stent implantation, Evolution Stent System, Biodegradable polymer coating, Feasibility study
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROMUS(TM) Element (TM) Stent SystemDevice

    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 SystemDevice

    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).

Study groups in NCT01135225
Study groupRoleWhat they receive
PROMUS(TM) Element(TM) Coronary StentActive comparatorPROMUS(TM) Element(TM) Everolimus-Eluting Coronary Stent System
Receives: Device: PROMUS(TM) Element (TM) Stent System
Evolution Coronary Stent AExperimentalEvolution Everolimus-Eluting Monorail Coronary Stent System
Receives: Device: Evolution Stent System
Evolution Coronary Stent BExperimentalEvolution Everolimus-Eluting Monorail Coronary Stent System
Receives: Device: Evolution Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure

    Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure:

    • Cardiac Death related to target vessel
    • Target Vessel Myocardial Infarction (TV-MI)
    • Target Lesion Revascularization (TLR)

    Measured: 30 days

  2. In-stent late loss at 6 month post-procedure

    In-stent late loss at 6 months post-procedure measured by Quantitative Coronary Angiography (QCA)

    Measured: 6 months post-procedure

Secondary outcomes (8)

  1. Target lesion revascularization (TLR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

    Measured: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  2. Target vessel revascularization (TVR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

    Measured: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  3. Target lesion failure (TLF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

    Measured: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  4. Target vessel failure (TVF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

    Measured: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  5. Cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

    Measured: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  6. Non-cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

    Measured: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  7. MI rate (TV and overall)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

    Measured: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  8. Stent thrombosis rate (by Academic Research Consortium [ARC] definition)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

    Measured: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionAug 2011
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01135225
Sponsor's protocol ID
S2060
Acronym
Evolve
Status last verified
Feb 2017
First submitted
31 May 2010
Last updated
3 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23872647

  • 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.

    PubMed 22341736

Questions about this trial

What is this clinical trial studying?

A study testing PROMUS(TM) Element (TM) Stent System and Evolution Stent System in people with Coronary Artery Disease, run by Boston Scientific Corporation at 29 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 67 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United Kingdom, Australia, Belgium, France, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01135225, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.

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