Clinical trial NCT04100499: Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR
Official title: Evaluation of Adjunctive Use of EndoAnchors During of After EVAR and TEVAR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Thoracic Aortic Aneurysm
Keywords: Endoanchors
EVAR
TEVAR
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with abdominal or thoracic aneurysms.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of participants with type IA Endoleaks
timeFrame: Three years
Secondary outcomes:
measure: Rate of participants with Endograft Migration
timeFrame: Three years
measure: Rate of participants with Sac regression
timeFrame: Three years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Vascular Surgery Department
Study officials:
affiliation: Vascular Surgery Department
name: Andres Reyes Valdivia, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reyes Valdivia A, Duque Santos A, Pitoulias G, Aracil Sanus E, Ocana Guaita J, Gandarias Zuniga C. Predictors of inadequate EndoAnchors aortic wall penetration for the Endosutured therapy in hostile neck patients. J Cardiovasc Surg (Torino). 2020 Dec;61(6):738-744. doi: 10.23736/S0021-9509.20.11248-5. Epub 2020 Jun 19.
citation: Reyes Valdivia A, Busto Suarez S, Duque Santos A, Zanabili Al-Sibbai AA, Gandarias Zuniga C, Chaudhuri A. Evaluation of EndoAnchor Aortic Wall Penetration After Thoracic Endovascular Aortic Repair. J Endovasc Ther. 2020 Apr;27(2):240-247. doi: 10.1177/1526602820907564.
citation: Reyes Valdivia A, Milner R, Heijmen R, Riambau V, Rousseau H, Tinelli G, Kotelis D, Zanabili Al-Sibbai AA, Pitoulias G, Zuniga CG, de Beaufort HWL, Panagiotis D, Chaudhuri A. Mid-term outcomes of the use of endoanchors during thoracic endovascular aortic repair in multicentre analysis. Vascular. 2023 Jun;31(3):455-462. doi: 10.1177/17085381221076320. Epub 2022 Feb 27.
citation: Reyes Valdivia A, Chaudhuri A, Milner R, Pratesi G, Reijnen MM, Tinelli G, Schuurmann R, Barbante M, Babrowski TA, Pitoulias G, Tshomba Y, Gandarias C, Badawy A, de Vries JP. Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry. Vascular. 2022 Feb;30(1):27-37. doi: 10.1177/1708538121992596. Epub 2021 Feb 10.