Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR
- Conditions
- Aortic AneurysmThoracic Aortic Aneurysm
- Registration Number
- NCT04100499
- Lead Sponsor
- Hospital Universitario Ramon y Cajal
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- All consecutive patients with adjunctive use of EndoAnchors during or after EVAR and TEVAR
- Patients that don't want te receive any repair for their disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of participants with type IA Endoleaks Three years Absence of type IA Endoleaks during follow-up
- Secondary Outcome Measures
Name Time Method Rate of participants with Endograft Migration Three years Analysis of Endograft migration during follow-up
Rate of participants with Sac regression Three years Analysis of Sac regression during follow-up
Trial Locations
- Locations (1)
Vascular Surgery Department
🇪🇸Madrid, Spain