Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR

February 8, 2021 updated by: Andrés Reyes Valdivia, Hospital Universitario Ramon y Cajal

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andres Reyes Valdivia, Consultant
  • Phone Number: +34629586239
  • Email: cauzaza@hotmail.com

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Recruiting
        • Vascular Surgery Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with abdominal or thoracic aneurysms.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants with type IA Endoleaks
Time Frame: Three years
Absence of type IA Endoleaks during follow-up
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants with Endograft Migration
Time Frame: Three years
Analysis of Endograft migration during follow-up
Three years
Rate of participants with Sac regression
Time Frame: Three years
Analysis of Sac regression during follow-up
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Ramon y Cajal

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Anticipated)

November 19, 2022

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 187/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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