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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)
Scientific title
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
Secondary ID [1] 0 0
Anchor Post Market Registry
Universal Trial Number (UTN)
Trial acronym
ANCHOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
Timepoint [1] 0 0
Through 12 months
Primary outcome [2] 0 0
Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
Timepoint [2] 0 0
Through 12 months
Primary outcome [3] 0 0
Protocol C has composite primary safety endpoint
Timepoint [3] 0 0
Through 12 months
Primary outcome [4] 0 0
Protocol C have composite primary effectiveness endpoint
Timepoint [4] 0 0
Through 12 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Through 5 years
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Through 5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/12/2025
Actual
Sample size
Target
Accrual to date
Final
1090
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Dandenong Hospital - Dandenong
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment postcode(s) [1] 0 0
NSW 2139 - Concord
Recruitment postcode(s) [2] 0 0
VIC 3175 - Dandenong
Recruitment postcode(s) [3] 0 0
WA 6000 - Perth
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
NSW 2065 - St. Leonards
Recruitment outside Australia
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Alabama
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Rennes
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Berlin
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Heidelberg
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Leipzig
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Lingen
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Munster
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Nuremberg
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Roma
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Salerno
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Siena
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Torino
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Arnhem
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Enschede
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Utrecht
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Auckland
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Nové Mesto
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Barcelona
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Malmo
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Lausanne
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Liverpool
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London
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Manchester
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United Kingdom
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Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jean-Paul de Vries, MD
Address 0 0
Universitair Medisch Centrum Groningen, Netherlands
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT01534819