Trials / Completed
CompletedNCT01534819
ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,090 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EndoAnchor™ | Use of the EndoAnchor™ in conjunction with endograft |
| PROCEDURE | endovascular treament | implantation of a device inserted through an artery |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2020-11-12
- Completion
- 2026-04-08
- First posted
- 2012-02-17
- Last updated
- 2026-04-14
Locations
87 sites across 13 countries: United States, Australia, Austria, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01534819. Inclusion in this directory is not an endorsement.