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

Active, not recruiting

• Conditions: Aortic Aneurysm

• Registration Number: NCT01534819
• Lead Sponsor: Medtronic Cardiovascular

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.

Study Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Study Start: 2012-04-01
• Primary Completion: 2020-11-12
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-08
• Study Completion: 2025-12-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1090

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (87)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Abrazo Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

John L McClellan Memorial Veterans Hospital; 🇺🇸 Little Rock, Arkansas, United States

VA Loma Linda Medical Center; 🇺🇸 Loma Linda, California, United States

El Camino Hospital; 🇺🇸 Mountain View, California, United States

University of California Irvine Medical Center; 🇺🇸 Torrance, California, United States

Harbor - UCLA Medical Center; 🇺🇸 Torrance, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

MedStar Georgetown University Hospital Vascular Surgery Dept.; 🇺🇸 Washington, District of Columbia, United States

Baptist Cardiac & Vascular Institute; 🇺🇸 Miami, Florida, United States

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