Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR

Sponsor

Hospital Universitario Ramon y Cajal (Other)

Overall Status

Recruiting

CT.gov ID

NCT04100499

Collaborator

(none)

300

Enrollment

Location

34.6

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm Thoracic Aortic Aneurysm	Device: ESAR (Endosutured Aneurysm Repair)

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Dec 31, 2019

Actual Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Nov 19, 2022

Outcome Measures

Primary Outcome Measures

Rate of participants with type IA Endoleaks [Three years]
Absence of type IA Endoleaks during follow-up

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vascular Surgery Department	Madrid		Spain	28034

Sponsors and Collaborators

Hospital Universitario Ramon y Cajal

Investigators

Principal Investigator: Andres Reyes Valdivia, Consultant, Vascular Surgery Department

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Andrés Reyes Valdivia, Principal Investigator, Hospital Universitario Ramon y Cajal

ClinicalTrials.gov Identifier:

NCT04100499

Other Study ID Numbers:

187/19

First Posted:

Sep 24, 2019

Last Update Posted:

Feb 11, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Andrés Reyes Valdivia, Principal Investigator, Hospital Universitario Ramon y Cajal

Endoanchors

EVAR

TEVAR

Additional relevant MeSH terms:

Aneurysm

Aortic Aneurysm

Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of Feb 11, 2021