Evaluation of Adjunctive Use of EndoAnchors During of After EVAR and TEVAR
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Rate of participants with type IA Endoleaks
Study Overview
Brief Summary
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR.
The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)
Detailed Description
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed designed to improve the Endovascular aortic repair. This device is described to mimic an open surgical anastomosis during or after EVAR/TEVAR.
The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study), these outcomes will be described in terms of type IA Endoleaks, migration and sac regression.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All consecutive patients with adjunctive use of EndoAnchors during or after EVAR and TEVAR
Exclusion Criteria
- •Patients that don't want te receive any repair for their disease
Outcomes
Primary Outcomes
Rate of participants with type IA Endoleaks
Time Frame: Three years
Absence of type IA Endoleaks during follow-up
Secondary Outcomes
- Rate of participants with Endograft Migration(Three years)
- Rate of participants with Sac regression(Three years)
Investigators
Andrés Reyes Valdivia
Principal Investigator
Hospital Universitario Ramon y Cajal