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.
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.
Brief Title
ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
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.
Completion Date
Completion Date Type
Estimated
Conditions
Aortic Aneurysm
Eligibility 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
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.
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
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.
Inclusion Criteria
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
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
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
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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01534819
Org Class
Industry
Org Full Name
Medtronic Cardiovascular
Org Study Id
Anchor Post Market Registry
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
Primary Outcomes
Outcome Description
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
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
Outcome Measure
Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
Outcome Time Frame
Through 12 months
Outcome Description
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
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
Outcome Measure
Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms
Outcome Time Frame
Through 12 months
Outcome Description
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
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
Outcome Measure
Protocol C has composite primary safety endpoint
Outcome Time Frame
Through 12 months
Outcome Description
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
1. migration at 12 months and
2. Type I endoleak at the targeted attachment site(s) at 12 months
Outcome Measure
Protocol C have composite primary effectiveness endpoint
Outcome Time Frame
Through 12 months
Secondary Outcomes
Outcome Description
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
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
Outcome Time Frame
Through 5 years
Outcome Measure
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.
Outcome Description
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
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
Outcome Time Frame
Through 5 years
Outcome Measure
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.
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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
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
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Evan Lipsitz
Investigator Email
elipsitz@montefiore.org
Investigator Phone