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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01534819
Registration number
NCT01534819
Ethics application status
Date submitted
9/02/2012
Date registered
17/02/2012
Titles & IDs
Public title
ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
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Scientific title
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
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Secondary ID [1]
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Anchor Post Market Registry
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Universal Trial Number (UTN)
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Trial acronym
ANCHOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysm
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - EndoAnchor™
Treatment: Surgery - endovascular treament
Protocol B, abdominal arm, revision group - AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak
Protocol B, abdominal arm, primary group - AAA 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.
Protocol B, thoracic arm, revision group - TAA 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
Protocol B, thoracic arm, primary group - TAA 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
Protocol B, advanced disease arm, revision group - Advanced 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
Protocol B, advanced disease arm, primary group - Advanced 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.
Protocol C, abdominal arm, short neck, primary group - Planned 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.
Treatment: Devices: EndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
Treatment: Surgery: endovascular treament
implantation of a device inserted through an artery
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
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Assessment method [1]
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The primary safety endpoint is defined by:
i. 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
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Timepoint [1]
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Through 12 months
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Primary outcome [2]
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Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
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Assessment method [2]
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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
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Timepoint [2]
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Through 12 months
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Primary outcome [3]
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Protocol C has composite primary safety endpoint
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Assessment method [3]
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The primary safety endpoint is defined by:
1. device-related serious adverse events at 12 months
2. 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
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Timepoint [3]
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Primary outcome [4]
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Protocol C have composite primary effectiveness endpoint
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Assessment method [4]
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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
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Timepoint [4]
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Secondary outcome [1]
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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.
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Assessment method [1]
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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
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Timepoint [1]
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Secondary outcome [2]
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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.
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Assessment method [2]
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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
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Timepoint [2]
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Eligibility
Key inclusion criteria
Protocol B:
Inclusion criteria:
1. Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms
2. Subject = 18 years old
3. Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
4. Subject is willing and able to comply with standard of care followup evaluations
5. 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
* 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
6. 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)
7. 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
2. Subject has a life expectancy of less than 1 year
3. 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
4. Subject was treated with EndoAnchor™ in the same segment of the aorta that will be treated in the registry
5. Subject has an active or known history of bleeding diathesis
6. Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
7. Significant thrombus or calcium at the location of planned EndoAnchor™ implantation that precludes adequate EndoAnchor™ penetration of the aortic wall
8. Use where, for whatever reason, each EndoAnchor™ is not anticipated to adequately penetrate into the aortic wall
9. Subject has an aortic dissection that involves an area to be treated with EndoAnchor™
10. Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
11. Subject is pregnant
Protocol C:
Inclusion criteria:
* 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
Exclusion criteria:
* 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
3/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
1090
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Dandenong Hospital - Dandenong
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Royal Perth Hospital - Perth
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Sir Charles Gairdner Hospital - Perth
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Royal North Shore Hospital - St. Leonards
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NSW 2139 - Concord
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VIC 3175 - Dandenong
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WA 6000 - Perth
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- Perth
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NSW 2065 - St. Leonards
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Funding & Sponsors
Primary sponsor type
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Name
Medtronic Cardiovascular
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Ethics approval
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT01534819
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Trial related presentations / 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. 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. 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. 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. 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Jean-Paul de Vries, MD
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Address
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Universitair Medisch Centrum Groningen, Netherlands
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Ark...
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Journal
Jordan WD Jr, Mehta M, Ouriel K, Arko FR, Varnagy ...
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Results not provided in
https://clinicaltrials.gov/study/NCT01534819