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NCT04100499 Clinical Trial

Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR

Aortic Aneurysm Clinical Trial

Official title:
Evaluation of Adjunctive Use of EndoAnchors During of After EVAR and TEVAR

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04100499
Other study ID # 187/19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 31, 2019
Est. completion date November 19, 2022

Study information
Verified date February 2021
Source Hospital Universitario Ramon y Cajal
Contact Andres Reyes Valdivia, Consultant
Phone +34629586239
Email cauzaza@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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)

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 information / eligibility
Status Recruiting
Enrollment 300
Est. completion date November 19, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ESAR (Endosutured Aneurysm Repair)
EndoAnchors adjunctive therapy for EVAR and TEVAR

Locations
Country Name City State
Spain Vascular Surgery Department Madrid

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Reyes Valdivia A, Busto Suárez S, Duque Santos Á, Zanabili Al-Sibbai AA, Gandarias Zúñiga 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. — View Citation

Reyes Valdivia A, Duque Santos Á, Pitoulias G, Aracil Sanus E, Ocaña Guaita J, Gandarias Zúñiga 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of participants with type IA Endoleaks Absence of type IA Endoleaks during follow-up Three years
Secondary Rate of participants with Endograft Migration Analysis of Endograft migration during follow-up Three years
Secondary Rate of participants with Sac regression Analysis of Sac regression during follow-up Three years
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