ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Protocol B:
Inclusion criteria:
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Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms
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Subject ≥ 18 years old
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Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
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Subject is willing and able to comply with standard of care followup evaluations
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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
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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)
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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:
- 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)
- 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:
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.
Trial design
1,090 participants in 7 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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