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Coronary Artery DiseasePhase 3NCT01665053

The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

A Phase 3 study testing PROMUS Element Plus and SYNERGY in people with Coronary Artery Disease, run by Boston Scientific Corporation at 126 sites in 16 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 this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual… 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 Element Plus and SYNERGY
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,684 participants
Where
126 sitesin 16 countries
Study dates
Nov 2012to 22 Dec 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subject must be at least 18 years of age
  • Subject (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
  • For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
  • Subject is eligible for percutaneous coronary intervention (PCI)
  • Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
  • Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
Show all 13Show fewer
  • Subject is willing to comply with all protocol-required follow-up evaluation
  • Angiographic Inclusion Criteria (visual estimate):
  • Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
  • Target lesion(s) length must be ≤34 mm (by visual estimate)
  • Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
  • Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
  • The first lesion treated must be successfully predilated/pretreated

Who cannot join

  • Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
  • Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
  • Subject has received an organ transplant or is on a waiting list for an organ transplant
  • Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
  • Planned PCI (including staged procedures) or CABG after the index procedure
  • Subject previously treated at any time with intravascular brachytherapy
Show all 39Show fewer
  • Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
  • Subject has one of the following (as assessed prior to the index procedure):
  • Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of 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
  • Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
  • Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
  • Subject has a white blood cell (WBC) count < 3,000 cells/mm3
  • Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
  • Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  • Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
  • Subject has severe symptomatic heart failure (i.e., NYHA class IV)
  • Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
  • Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  • Subject 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)
  • Subject 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)
  • Angiographic Exclusion Criteria (visual estimate):
  • Planned treatment of more than 3 lesions
  • Planned treatment of lesions in more than 2 major epicardial vessels
  • Planned treatment of a single lesion with more than 1 stent
  • Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
  • Target lesion(s) is located in the left main
  • Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
  • Target lesion(s) is located within a saphenous vein graft or an arterial graft
  • Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
  • Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  • Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
  • Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
  • Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
  • Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
  • Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Trial locations and contacts

126 sites in 16 countries.

126 sites in 16 countries

United States69 sites

  • New Mexico Heart Institute, PA

    Albuquerque, New Mexico, 87042

  • Kings Daughters Medical Center

    Ashland, Kentucky, 41101

  • Bakersfield Memorial Hospital

    Bakersfield, California, 93301

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Baptist Medical Center - Princeton

    Birmingham, Alabama, 35211

  • Tufts Medical Center, Inc.

    Boston, Massachusetts, 02110

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02120

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Lindner Center for Research and Education at Christ Hosp

    Cincinnati, Ohio, 45219

  • Morton Plant Mease Healthcare

    Clearwater, Florida, 33756

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44103

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Sisters of Charity Providence Hospitals

    Columbia, South Carolina, 29204

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Mercy Hospital Medical Center

    Des Moines, Iowa, 50314

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • St Mary's Duluth Clinic

    Duluth, Minnesota, 55805

  • Northern Indiana Research Alliance

    Fort Wayne, Indiana, 46804

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina, 27401

  • Our Lady of Lourdes Medical Center

    Haddon Heights, New Jersey, 08035

  • Kaiser Foundation Hospital

    Honolulu, Hawaii, 96819

  • St. Vincent's Medical Group, Inc.

    Indianapolis, Indiana, 46290

  • Jackson Madison County Hospital

    Jackson, Tennessee, 38301

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • Wellstar Health Systems

    Marietta, Georgia, 30060

  • University of Miami McKnight Brain Institute

    Miami, Florida, 33138

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Mount Sinai - PRIME

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • New York Presbyterian Hospital

    New York, New York, 10065

  • MediQuest

    Ocala, Florida, 34471

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital Medical Center

    Orlando, Florida, 32803

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Rex Hospital

    Raleigh, North Carolina, 27607

  • Wake Heart Research, LLC

    Raleigh, North Carolina, 27610

  • Henrico Doctors Hospital

    Richmond, Virginia, 23229

  • St. David's Round Rock Medical Center

    Round Rock, Texas, 78681

  • University of California Davis Health System

    Sacramento, California, 95617

  • Sutter Memorial Hospital

    Sacramento, California, 95819

  • Methodist Texsan Hospital

    San Antonio, Texas, 78201

  • Alvarado Hospital Medical Center

    San Diego, California, 92121

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Prairie Cardiovascular Consultants, Ltd.

    Springfield, Illinois, 62701

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Tallahassee Research Institute, Inc.

    Tallahassee, Florida, 32308

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aspirus Heart & Vascular Institute

    Wausau, Wisconsin, 54401

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan12 sites

  • Shonan Kamakura General Hospital

    Kamakura-shi, Kanagawa, 247-8533

  • Kokura Memorial Hospital

    Kitakyushu-shi, Fukuoka, 802-8555

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo-To, 153-8515

  • The Cardiovascular Institute

    Minatoku, Tokyo-To, 106-0031

  • Showa University Hospital

    Shinagawa-ku, Tokyo-To, 142-8666

  • Department of Cardiology, Tokyo Women's Medical University

    Shinjuku-ku, Tokyo-To, 162-8666

  • National Cerebral and Cardiovascular Center

    Suita-shi, Osaka, 565-8565

  • Teikyo University Hospital

    tabashi City, Tokyo-To, 173-8606

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo-To, 173-8610

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, Kanagawa, 230-8765

Other trials in Japan

France8 sites

  • CHU de Brest - Hôpital de la Cavale Blanche

    Brest, Finistere, 29609

  • Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

    Bron, Rhone, 69500

  • Centre Hospitalier de Lagny - Marne La Vallée

    Lagny-sur-Marne, 77600

  • Polyclinique Les Fleurs

    Ollioules, Var, 83192

  • Hôpital Cochin

    Paris, 75014

  • Clinique Saint-Hilaire - Centre Frédéric Joliot

    Rouen, Seine Maritime, 76000

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, Haute Garonne, 31059

  • Clinique Pasteur - Toulouse

    Toulouse, Haute Garonne, 31076

Other trials in France

Canada5 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • Institut de Cardiologie de Montreal

    Montreal, Quebec, H1T 1C8

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Sainte-Foy, Quebec, G1V 4G5

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M4

Other trials in Canada

Australia4 sites

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Monash Medical Centre-Clayton Campus

    Clayton, Victoria, 3168

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

Other trials in Australia

Belgium4 sites

  • Imelda Ziekenhuis

    Bonheiden, 2820

  • Z.O.L - Campus St. Jan

    Genk, 3600

  • UZ Leuven

    Leuven, 3000

  • HHrm

    Roeselare, 8800

Other trials in Belgium

New Zealand4 sites

  • Ascot Angiography Ltd

    Auckland, 1050

  • Middlemore Hospital

    Auckland, 1640

  • North Shore Hospital

    Auckland, 622

  • Christchurch Hospital NZ

    Christchurch, 8011

Other trials in New Zealand

Italy3 sites

  • Umberto I Pol. di Roma-Università di Roma La Sapienza

    Roma, 161

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Netherlands3 sites

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Medisch Spectrum Twente, Haaksbergerstraat

    Enschede, 7513 ER

  • St. Antonius Ziekenhuis, Nieuwegein

    Nieuwegein, 3435CM

Other trials in Netherlands

Poland3 sites

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • SK Przemienienia Panskiego UM im.K.Marcinkowskiego

    Poznan, 61-848

  • Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

    Warsaw, 04-628

Other trials in Poland

Spain3 sites

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

Austria2 sites

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg

  • AKH - Medizinische Universität Wien

    Vienna

Other trials in Austria

Finland2 sites

  • University Hospital, Heart Centre

    Tampere, 33521

  • Turku University Hospital

    Turku, FI-20520

Other trials in Finland

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • National Heart Centre

    Singapore, 168752

Other trials in Singapore

Denmark1 site

  • Rigshospitalet Copenhagen

    Copenhagen, 2100

Other trials in Denmark

Latvia1 site

  • P. Stradins Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

About this study

Official title: EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Read the detailed description

A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.

Being tested
PROMUS Element Plus, SYNERGY
Keywords
Drug-Eluting Stents
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 Element PlusDevice

    A drug eluting coronary stent system

  • SYNERGYDevice

    A drug eluting coronary stent system

Study groups in NCT01665053
Study groupRoleWhat they receive
Promus Element PlusActive comparatorPROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
Receives: Device: PROMUS Element Plus
SYNERGYExperimentalSYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
Receives: Device: SYNERGY

What is being measured

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

  1. Percentage of Participants With Target Lesion Failure (TLF) at 12 Months

    TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

    Measured: 12 months

Secondary outcomes (16)

  1. Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.

    The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) \& TLR Coronary Artery Bypass Graft (CABG).

    Measured: 12 months

  2. Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.

    TVR overall includes: TVR PCI \& TVR CABG.

    Measured: 12 months

  3. Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.

    Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.

    Measured: 12 months

  4. Percentage of Participants With Myocardial Infarction at 12 Month.

    The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.

    Measured: 12 months

  5. Percentage of Participants With Cardiac Death at 12 Month.

    Measured: 12 months

  6. Percentage of Participants With Non-Cardiac Death at 12 Month.

    Measured: 12 months

  7. Percentage of Patients That Died at 12 Months.

    The Death rate includes Cardiac- \& Non-Cardiac Death.

    Measured: 12 months

  8. Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.

    Measured: 12 months

  9. Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.

    Measured: 12 months

  10. Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.

    Measured: 12 months

  11. Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.

    Measured: 12 months

  12. Percentage of Patients With a Stroke at 12 Month.

    The stroke rate includes: Ischemic- , Hemorraghic- \& Undetermined Stroke.

    Measured: 12 months

  13. Periprocedural Technical Success Rate.

    Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.

    Measured: Day 1 (periprocedure)

  14. Periprocedural Clinical Procedural Success Rate

    Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.

    Measured: Day 1 (periprocedure)

  15. Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.

    Measured: 12 month

  16. Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.

    All CEC adjudicated revascularization at 12 month (Intent to treat population).

    Measured: 12 Month

Timeline

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

  1. First posted15 Aug 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionSep 2014
  4. Study completion22 Dec 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,684 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01665053
Sponsor's protocol ID
S2067
Other IDs
G120123
Status last verified
Jan 2019
First submitted
7 Aug 2012
Last updated
30 Jan 2019
Data monitoring committee
Yes

Publications

  • Kereiakes DJ, Windecker S, Jobe RL, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Underwood P, Allocco DJ, Meredith IT. Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27.

    PubMed 31451014

  • Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.

    PubMed 25855680

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PROMUS Element Plus and SYNERGY in people with Coronary Artery Disease, run by Boston Scientific Corporation at 126 sites in 16 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 13 inclusion and 39 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in United States, Japan, France, Canada, Australia and 11 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Target Lesion Failure (TLF) at 12 Months (time frame: 12 months). 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 NCT01665053, 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 30 Jan 2019.

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