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Aortic AneurysmANCHORNCT01534819

ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)

An observational study of Aortic Aneurysm, run by Medtronic Cardiovascular at 87 sites in 13 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 ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Aneurysm
What is being tested?
EndoAnchor™ and endovascular treament
How many people
1,090 participants
Where
87 sitesin 13 countries
Study dates
Apr 2012to 8 Apr 2026
Phase
Observational
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

Study population: Protocol B: subjects with AAA, TAA, or advanced aortic aneurysmal disease treated with the Heli-FX™ EndoAnchor™ System in conjunction with commercially available abdominal and thoracic Endografts, in both "Primary" and "Revision" settings and who meet the inclusion/exclusion criteria. Protocol C:The intended population will include those subjects with short (≥ 4 mm and < 10 mm) infrarenal proximal neck lengths who are appropriate candidates for infrarenal AAA treatment with the Heli-FX™ EndoAnchor™ System in conjunction with the Endurant II/IIs endograft system and who meet the inclusion/exclusion criteria

Who may be able to join

  • Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms
  • Subject ≥ 18 years old
  • Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
  • Subject is willing and able to comply with standard of care followup evaluations
  • Subject has a previously implanted endograft or will be undergoing repair, with one of the following aortic aneurysm endograft devices:
  • Cook Zenith or Cook Zenith TX2
Show all 22Show fewer
  • Gore Excluder or TAG
  • Medtronic AneuRx
  • Medtronic Talent
  • Medtronic Endurant or Valiant
  • Any additional third party AAA endograft device that is commercially available and listed as compatible with Heli-FX™ in the IFU
  • Subject's iliac/femoral access is compatible with:
  • a 16 French sheath (abdominal subjects)
  • 18 French sheath (thoracic subjects)
  • Selected 16 or 18 French sheath, as applicable to the device selected for use (advanced disease subjects)
  • Subject has a previously implanted endograft that has migrated or has a Type I endoleak within the aorta or will undergo implantation of an endograft that in the opinion of the investigator will be at increased risk of such complications
  • Subjects with asymptomatic or symptomatic abdominal aortic aneurysms that will receive the Heli-FX™ in conjunction with the Endurant II/IIs endograft as part of their planned EVAR treatment
  • Subject ≥ 18 years old
  • Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
  • Subject is willing and able to comply with standard of care followup evaluations
  • Subject will be undergoing AAA repair with the bifurcated main body Endurant II/IIs stent graft in conjunction with Heli-FX™ with a proximal neck length of ≥ 4mm to < 10mm and treated in accordance with the Endurant II/IIs and Heli-FX™ IFUs
  • Subject's iliac/femoral access is compatible with a 16 French sheath

Who cannot join

  • Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
  • Subject has a life expectancy of less than 1 year
  • Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
  • Subject was treated with EndoAnchor™ in the same segment of the aorta that will be treated in the registry
  • Subject has an active or known history of bleeding diathesis
  • Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
Show all 24Show fewer
  • Significant thrombus or calcium at the location of planned EndoAnchor™ implantation that precludes adequate EndoAnchor™ penetration of the aortic wall
  • Use where, for whatever reason, each EndoAnchor™ is not anticipated to adequately penetrate into the aortic wall
  • Subject has an aortic dissection that involves an area to be treated with EndoAnchor™
  • Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
  • Subject is pregnant
  • Protocol C:
  • Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
  • Subject has a life expectancy of less than 1 year
  • Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
  • Subject was previously treated with EndoAnchor™ implants in the same segment of the aorta that will be treated within the registry, or has a previously implanted AAA endograft that has migrated or has a Type Ia endoleak, or is being treated for a ruptured abdominal aortic aneurysm, or has planned usage of an Endurant II/IIs AUI main body stent graft configuration
  • Subject has an active or known history of bleeding diathesis
  • Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
  • Significant thrombus or calcium at the location of planned EndoAnchor™ device implantation that precludes adequate EndoAnchor™ implant penetration of the aortic wall
  • Use where, for whatever reason, each EndoAnchor™ implant is not anticipated to adequately penetrate into the aortic wall
  • Subject has an aortic dissection that involves an area to be treated with EndoAnchor™ implants
  • Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
  • Subject is pregnant
  • Physician does not intend to treat subject on-label per the Endurant II/IIs and Heli-FX™ IFU requirements or if the physician intends to use Heli-FX™ in a chimney procedure.

Trial locations and contacts

87 sites in 13 countries.

87 sites in 13 countries

United States46 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Mission Hospital

    Asheville, North Carolina, 28806

  • Emory University Hospital

    Atlanta, Georgia, 30322-1059

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21401

  • University of Alabama

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess-Harvard

    Boston, Massachusetts, 02215

  • University of North Carolina (UNC) Memorial Hospital

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • CHI Memorial Hospital Chattanooga

    Chattanooga, Tennessee, 37403

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Michigan Vascular Center

    Flint, Michigan, 98507

  • Kaiser Permanente Moanalua Medical Center and Clinic

    Honolulu, Hawaii, 96819

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • John L McClellan Memorial Veterans Hospital

    Little Rock, Arkansas, 72205

  • VA Loma Linda Medical Center

    Loma Linda, California, 92357

  • Baptist Memorial Hospital-Memphis

    Memphis, Tennessee, 38120

  • Baptist Cardiac & Vascular Institute

    Miami, Florida, 33176

  • El Camino Hospital

    Mountain View, California, 94040

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • New York University Langone Medical Center

    New York, New York, 10016

  • The Mount Sinai Hospital

    New York, New York, 10029

  • Maimonides Medical Center

    New York, New York, 11219

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Florida Hospital

    Orlando, Florida, 32751

  • HeartCare Midwest

    Peoria, Illinois, 61614

  • Abrazo Arizona Heart Institute

    Phoenix, Arizona, 84006

  • Vascular Health Partners

    Queensbury, New York, 12804

  • William Beaumont Hospital

    Royal Oak, Michigan, 48703

  • Harborview Medical Center, University of Washington

    Seattle, Washington, 98104

  • Evanston Hospital

    Skokie, Illinois, 60077

  • Southern Illinois University

    Springfield, Illinois, 62702

  • Washington University School of Medicine, Barnes Jewish West County Hospital

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • University of South Florida

    Tampa, Florida, 33606

  • Scott and White Medical Center

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of California Irvine Medical Center

    Torrance, California, 90502-2004

  • Harbor - UCLA Medical Center

    Torrance, California, 90509

  • MedStar Georgetown University Hospital Vascular Surgery Dept.

    Washington D.C., District of Columbia, 20007

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

  • UPMC Pinnacle Harrisburg Campus

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Germany10 sites

  • Medizinische Fakultät der RWTH

    Aachen

  • Deutsches Herzzentrum

    Berlin

  • University Hospital Heidelberg

    Heidelberg

  • Park Hospital Leipzig

    Leipzig

  • St. Bonifatius Hospital

    Lingen

  • Klinikum Ludwigsburg

    Ludwigsburg

  • LMU Kilinikum der Universitaet Muenchen

    Munich

  • Technical University of Munich

    Munich

  • St. Franzsikus-Hospital GmbH

    Münster

  • Klinikum Nuremberg

    Nuremberg

Other trials in Germany

Australia5 sites

  • Concord Repatriation General Hospital

    Concord, NSW 2139

  • Dandenong Hospital

    Dandenong, VIC 3175

  • Royal Perth Hospital

    Perth, WA 6000

  • Sir Charles Gairdner Hospital

    Perth

  • Royal North Shore Hospital

    St Leonards, NSW 2065

Other trials in Australia

Italy5 sites

  • Azienda Ospedaliero-Universitaria Careggi

    Florence

  • AO Universitaria Policlinico

    Roma

  • Unihospital San Giovanni di Dio Ruggi d'Aragona

    Salerno, 84131

  • University of Siena

    Siena

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino

Other trials in Italy

Netherlands5 sites

  • Rijnstate Hospital

    Arnhem

  • Medisch Spectrum Twente

    Enschede

  • St. Antonius Hospital

    Nieuwegein

  • Maasstad Hospital Rotterdam

    Rotterdam

  • UMC Utrecht

    Utrecht

Other trials in Netherlands

United Kingdom4 sites

  • The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

    Liverpool

  • Imperial College Healthcare NHS Trust

    London

  • Wythenshawe Hospital

    Manchester

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

    Newcastle upon Tyne

Other trials in United Kingdom

Spain3 sites

  • Thorax Institute Hospital Clinic

    Barcelona

  • Hospital Universitario Donostia

    Donostia / San Sebastian

  • Hospital Clínico Universitario de Valladolid

    Valladolid

Other trials in Spain

Austria2 sites

  • A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

    Innsbruck

  • Allgemeines Krankenhaus - Universitätskliniken Wien

    Vienna

Other trials in Austria

France2 sites

  • Hôpital Pontchaillou

    Rennes

  • Nouvel Hôpital Civil

    Strasbourg

Other trials in France

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

  • UniversitätsSpital Zürich

    Zurich

Other trials in Switzerland

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

Slovakia1 site

  • Narodny ustav srdcovych a cievnych chorob

    Nové Mesto

Other trials in Slovakia

Sweden1 site

  • Malmo University Hospital

    Malmö

Other trials in Sweden

About this study

Official title: Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study.

Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure.

Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.

Read the detailed description

The objective of the ANCHOR registry is to expand the clinical knowledge based on the use of the Heli-FX™ EndoAnchor™ System. This registry will include "real world" use over a broad spectrum of geographies, by a wide variety of practicing clinicians, and with a minimal degree of subject selection criteria.

Conditions
Aortic Aneurysm
Being tested
EndoAnchor™, endovascular treament
Keywords
Endograft, Endurant, Heli-FX™, EndoAnchor™, Short neck, Endovascular treatment, Interventional treatment of aortic aneurysm, Abdominal aortic aneurysm, AAA, Thoracic aortic aneurysm, TAA, Advanced disease
Medical subject headings
Aortic Aneurysm, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic

What participants receive

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

  • EndoAnchor™Device

    Also called Heli-FX™, Heli-FX™ EndoAnchor™ System

    Use of the EndoAnchor™ in conjunction with endograft

  • endovascular treamentProcedure or surgery

    implantation of a device inserted through an artery

Study groups in NCT01534819
Study groupRoleWhat they receive
Protocol B, abdominal arm, revision groupAAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak
Receives: Device: EndoAnchor™; Procedure: endovascular treament
Protocol B, abdominal arm, primary groupAAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type Ia endoleak, or to treat Type Ia endoleak evident at the time of implantation.
Receives: Device: EndoAnchor™; Procedure: endovascular treament
Protocol B, thoracic arm, revision groupTAA subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
Receives: Device: EndoAnchor™; Procedure: endovascular treament
Protocol B, thoracic arm, primary groupTAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation
Receives: Device: EndoAnchor™; Procedure: endovascular treament
Protocol B, advanced disease arm, revision groupAdvanced disease subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site
Receives: Device: EndoAnchor™; Procedure: endovascular treament
Protocol B, advanced disease arm, primary groupAdvanced disease subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation.
Receives: Device: EndoAnchor™; Procedure: endovascular treament
Protocol C, abdominal arm, short neck, primary groupPlanned use of Heli-FX™ in conjunction with the Endurant II/IIs endograft in AAA subjects with short proximal necks (≥ 4 mm and < 10 mm) in primary group.
Receives: Device: EndoAnchor™; Procedure: endovascular treament

What is being measured

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

  1. Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms

    The primary safety endpoint is defined by:

    1. freedom from device-related serious adverse events at 12 months and ii. freedom from procedure-related serious adverse events at 12 months iii. freedom from aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm

    Measured: Through 12 months

  2. Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms

    The primary effectiveness endpoint requires all of the following:

    i successful implantation of the minimum number of EndoAnchor™ and ii freedom from migration at 12 months and iii freedom from Type I endoleak at the targeted attachment site(s) at 12 months

    Measured: Through 12 months

  3. Protocol C has composite primary safety endpoint

    The primary safety endpoint is defined by:

    1. device-related serious adverse events at 12 months
    2. aneurysm-related mortality defined as:
    3. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm

    Measured: Through 12 months

  4. Protocol C have composite primary effectiveness endpoint

    The primary effectiveness endpoint is treatment success which is defined as the successful implantation of EndoAnchor™ implants at the index procedure, and the absence of:

    1. migration at 12 months and
    2. Type I endoleak at the targeted attachment site(s) at 12 months

    Measured: Through 12 months

Secondary outcomes (2)

  1. Protocol B has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter.

    1. Technical success defined as successful deployment of EndoAnchor™ at their intended location. Technical success will be assessed separately for the target attachment sites; proximally and/or distally
    2. Clinical success will be defined as the successful implantation of the suggested number of EndoAnchor™ at the index procedure, and the absence of: death as a result of aneurysm-related treatment; Type Ia endoleak; Type Ib endoleak (TAA and advanced disease only); endograft infection; endograft migration; loss of endograft fabric integrity as a result of the EndoAnchor™; Rupture of the treated aneurysm; Conversion to open surgical repair
    3. Secondary aneurysm-related interventions after EndoAnchor™ implantation
    4. all-cause mortality
    5. Freedom from EndoAnchor™ fracture

    Measured: Through 5 years

  2. Protocol C has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter.

    1. Technical success defined as successful deployment of EndoAnchor™ at their intended location. Technical success will be assessed separately for the target attachment sites; proximally and/or distally
    2. Clinical success will be defined as the successful implantation of EndoAnchor™ at the index procedure, and the absence of: aneurysm-related mortality; Type Ia endoleak; endograft infection; endograft migration; loss of endograft fabric integrity as a result of the EndoAnchor™; Rupture of the treated aneurysm; Conversion to open surgical repair
    3. Secondary aneurysm-related interventions after EndoAnchor™ implantation
    4. all-cause mortality
    5. EndoAnchor™ implant fracture

    Measured: Through 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 posted17 Feb 2012 (estimated)
  2. Study startApr 2012
  3. Primary completion12 Nov 2020
  4. Study completion8 Apr 2026

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,090 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01534819
Sponsor's protocol ID
Anchor Post Market Registry
Acronym
ANCHOR
Status last verified
Apr 2026
First submitted
9 Feb 2012
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Ouriel K, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) Workgroup Members. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg. 2014 Oct;60(4):885-92.e2. doi: 10.1016/j.jvs.2014.04.063. Epub 2014 Jul 31.

    PubMed 25088739

  • Jordan WD Jr, Mehta M, Ouriel K, Arko FR, Varnagy D, Joye J, Moore WM Jr, de Vries JP. One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular. 2016 Apr;24(2):177-86. doi: 10.1177/1708538115590727. Epub 2015 Jun 10.

    PubMed 26069087

  • Arko FR 3rd, Pearce BJ, Henretta JP, Fugate MW, Torsello G, Panneton JM, Peng Y, Edward Garrett H Jr. Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry. J Vasc Surg. 2023 Dec;78(6):1418-1425.e1. doi: 10.1016/j.jvs.2023.07.058. Epub 2023 Aug 7.

    PubMed 37558144

  • van Noort K, Vermeulen JJM, Goudeketting SR, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, de Vries JPM. Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair. J Endovasc Ther. 2019 Jun;26(3):369-377. doi: 10.1177/1526602819837753. Epub 2019 Mar 25.

    PubMed 30907259

  • Arko FR 3rd, Stanley GA, Pearce BJ, Henretta JP, Fugate MW, Mehta M, Torsello G, Panneton JM, Garrett HE Jr. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg. 2019 Sep;70(3):732-740. doi: 10.1016/j.jvs.2018.11.033. Epub 2019 Mar 6.

    PubMed 30850297

  • Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699-1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18.

    PubMed 29248241

  • Jordan WD Jr, de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Henretta J. Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy. J Endovasc Ther. 2015 Apr;22(2):163-70. doi: 10.1177/1526602815574685.

    PubMed 25809354

  • Jordan WD Jr, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg. 2015 Jun;61(6):1383-90.e1. doi: 10.1016/j.jvs.2014.12.063. Epub 2015 Feb 28.

    PubMed 25735260

  • de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Jordan WD Jr; Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry ANCHOR Trial. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg. 2014 Dec;60(6):1460-7.e1. doi: 10.1016/j.jvs.2014.08.089. Epub 2014 Oct 3.

    PubMed 25284629

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Aneurysm, run by Medtronic Cardiovascular at 87 sites in 13 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 22 inclusion and 24 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Germany, Australia, Italy, Netherlands and 8 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?

Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms (time frame: Through 12 months). The study lists 4 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 NCT01534819, which also lists 9 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 14 Apr 2026.

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