The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01534819




Registration number
NCT01534819
Ethics application status
Date submitted
9/02/2012
Date registered
17/02/2012
Date last updated
18/06/2019

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 - 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
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 - 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
Timepoint [2] 0 0
Through 12 months
Primary outcome [3] 0 0
Protocol C has composite primary safety endpoint - The primary safety endpoint is defined by:
device-related serious adverse events at 12 months
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
Timepoint [3] 0 0
Through 12 months
Primary outcome [4] 0 0
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:
migration at 12 months and
Type I endoleak at the targeted attachment site(s) at 12 months
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. - 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
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
Secondary aneurysm-related interventions after EndoAnchor™ implantation
all-cause mortality
Freedom from EndoAnchor™ fracture
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. - 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
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
Secondary aneurysm-related interventions after EndoAnchor™ implantation
all-cause mortality
EndoAnchor™ implant fracture
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Hampshire
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Austria
State/province [25] 0 0
Innsbruck
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
France
State/province [27] 0 0
Creteil
Country [28] 0 0
France
State/province [28] 0 0
Rennes
Country [29] 0 0
France
State/province [29] 0 0
Strasbourg
Country [30] 0 0
Germany
State/province [30] 0 0
Aachen
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Frankfurt
Country [33] 0 0
Germany
State/province [33] 0 0
Heidelberg
Country [34] 0 0
Germany
State/province [34] 0 0
Leipzig
Country [35] 0 0
Germany
State/province [35] 0 0
Lingen
Country [36] 0 0
Germany
State/province [36] 0 0
Ludwigsburg
Country [37] 0 0
Germany
State/province [37] 0 0
Munich
Country [38] 0 0
Germany
State/province [38] 0 0
Munster
Country [39] 0 0
Germany
State/province [39] 0 0
Nuremberg
Country [40] 0 0
Germany
State/province [40] 0 0
Oldenburg
Country [41] 0 0
Germany
State/province [41] 0 0
Stuttgart
Country [42] 0 0
Italy
State/province [42] 0 0
Florence
Country [43] 0 0
Italy
State/province [43] 0 0
Roma
Country [44] 0 0
Italy
State/province [44] 0 0
Salerno
Country [45] 0 0
Italy
State/province [45] 0 0
Siena
Country [46] 0 0
Italy
State/province [46] 0 0
Torino
Country [47] 0 0
Netherlands
State/province [47] 0 0
Arnhem
Country [48] 0 0
Netherlands
State/province [48] 0 0
Enschede
Country [49] 0 0
Netherlands
State/province [49] 0 0
Groningen
Country [50] 0 0
Netherlands
State/province [50] 0 0
Nieuwegein
Country [51] 0 0
Netherlands
State/province [51] 0 0
Rotterdam
Country [52] 0 0
Netherlands
State/province [52] 0 0
Utrecht
Country [53] 0 0
New Zealand
State/province [53] 0 0
Auckland
Country [54] 0 0
Poland
State/province [54] 0 0
Szczecin
Country [55] 0 0
Slovakia
State/province [55] 0 0
Nové Mesto
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Donostia / San Sebastián
Country [58] 0 0
Spain
State/province [58] 0 0
Valladolid
Country [59] 0 0
Sweden
State/province [59] 0 0
Malmo
Country [60] 0 0
Switzerland
State/province [60] 0 0
Lausanne
Country [61] 0 0
Switzerland
State/province [61] 0 0
Zürich
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Bristol
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Liverpool
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Manchester
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Endovascular
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01534819
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
Michelle Endo
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
michelle.m.endo@medtronic.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01534819