Open Repair Versus Branched Endograft Repair for Treatment of Residual Chronic Aortic Arch Dissection During Follow-up After Open Type A Acute Ascending Aorta Replacement: Results From an International Multicenter Study.

March 15, 2025 updated by: TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
This study aims to evaluate peri-operative mortality and main post-operative complications (for example cardiovascular, respiratory and renal) in patients treated with frozen elephant trunk techinque.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

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

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00167
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing endovascular TAA repair with Frozen Elephant Trunk Technique

Description

Inclusion Criteria:

  • patients with post-dissection arch aneurysm with a maximal aortic diameter >55mm or rapid growth (>10mm/year)

Exclusion Criteria:

  • Emergency setting

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peri-operatory mortality
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operatory complications
Time Frame: 36 months
36 months

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

August 1, 2019

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 15530/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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