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Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR

Evaluation of Adjunctive Use of EndoAnchors During of After EVAR and TEVAR

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04100499
Enrollment
300
Registered
2019-09-24
Start date
2019-12-31
Completion date
2022-11-19
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Thoracic Aortic Aneurysm

Keywords

Endoanchors, EVAR, TEVAR

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.

Interventions

DEVICEESAR (Endosutured Aneurysm Repair)

EndoAnchors adjunctive therapy for EVAR and TEVAR

Sponsors

Hospital Universitario Ramon y Cajal
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Rate of participants with type IA EndoleaksThree yearsAbsence of type IA Endoleaks during follow-up

Secondary

MeasureTime frameDescription
Rate of participants with Endograft MigrationThree yearsAnalysis of Endograft migration during follow-up
Rate of participants with Sac regressionThree yearsAnalysis of Sac regression during follow-up

Countries

Spain

Contacts

Primary ContactAndres Reyes Valdivia, Consultant
cauzaza@hotmail.com+34629586239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026