ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)

A vizsgálat adatai

Ki végzi

Medtronic Cardiovascular

Azonosító

NCT01534819

A regiszteradat frissítve

2026. április 14.

Eredeti leírás

The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study.A teljes eredeti leírásKevesebb

Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

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.

Bevonási feltételek: Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms; 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 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; 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); 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; 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.

Kizáró feltételek: Subject was treated with EndoAnchor™ in the same segment of the aorta that will be treated in the registry; Subject has an aortic dissection that involves an area to be treated with EndoAnchor™; 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; 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 known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt); 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); Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease; Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt); 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); Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease; Significant thrombus or calcium at the location of planned EndoAnchor™ implantation that precludes adequate EndoAnchor™ penetration of the aortic wall; Significant thrombus or calcium at the location of planned EndoAnchor™ device implantation that precludes adequate EndoAnchor™ implant penetration of the aortic wall; 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; Use where, for whatever reason, each EndoAnchor™ is not anticipated to adequately penetrate into the aortic wall; Subject is pregnant; Protocol C:; 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 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.

Protocol B:.

ClinicalTrials.gov NCT01534819