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

N/AActive Not RecruitingNCT01534819

Medtronic Cardiovascular1,090 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,090

Conditions

Aortic Aneurysm

Interventions

EndoAnchor™DEVICE

Use of the EndoAnchor™ in conjunction with endograft

endovascular treamentPROCEDURE

implantation of a device inserted through an artery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (87)

Outcomes

Primary Outcomes

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

Time frame: Through 12 months

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

Time frame: Through 12 months

Protocol C has composite primary safety endpoint

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

Time frame: Through 12 months

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: 1. migration at 12 months and 2. Type I endoleak at the targeted attachment site(s) at 12 months

Time frame: Through 12 months

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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