Aortic Aneurysm
Conditions
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
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.
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.
Interventions
DEVICEEndoAnchor™
Use of the EndoAnchor™ in conjunction with endograft
PROCEDUREendovascular treament
implantation of a device inserted through an artery
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms | Through 12 months | 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 |
| Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms | Through 12 months | 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 |
| Protocol C has composite primary safety endpoint | Through 12 months | 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 |
| Protocol C have composite primary effectiveness endpoint | Through 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Through 5 years | 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 |
| 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. | Through 5 years | 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 |
Countries
Australia, Austria, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORJean-Paul de Vries, MD
Universitair Medisch Centrum Groningen, Netherlands
PRINCIPAL_INVESTIGATORWilliam Jordan, MD
Augusta University Health, United States
Outcome results
None listed