Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR

NCT04100499 | Unknown FDA Device

• 1 other identifier: 187/19
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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)

Conditions

Aortic Aneurysm; Thoracic Aortic Aneurysm

Keywords

Endoanchors; EVAR; TEVAR

Outcome Measures

Primary Outcomes (1)

• Rate of participants with type IA Endoleaks

  Absence of type IA Endoleaks during follow-up

  Three years

Secondary Outcomes (2)

• Rate of participants with Endograft Migration

  Three years

• Rate of participants with Sac regression

  Three years

Interventions

ESAR (Endosutured Aneurysm Repair) DEVICE

EndoAnchors adjunctive therapy for EVAR and TEVAR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with abdominal or thoracic aneurysms.

You may qualify if:

• All consecutive patients with adjunctive use of EndoAnchors during or after EVAR and TEVAR

You may not qualify if:

• Patients that don't want te receive any repair for their disease

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Vascular Surgery Department

Madrid, 28034, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 32558525 BACKGROUND

• 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.

  PMID: 32186262 BACKGROUND

• 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.

  PMID: 35225085 DERIVED

• 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.

  PMID: 33568007 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Andres Reyes Valdivia, Consultant

  Vascular Surgery Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andres Reyes Valdivia, Consultant

CONTACT

+34629586239; cauzaza@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 24, 2019
• Study Start: December 31, 2019
• Primary Completion: December 31, 2020
• Study Completion: November 19, 2022
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

ES (1)