Outcomes of Secondary Endovascular Aortic Repair After Initial Frozen Elephant Trunk Procedure

NCT05571930 | Completed DMC

• 1 other identifier: TEVAR after THX
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective Complex aortic pathology has been revolutionized with the use of hybrid prostheses such as the Thoraflex® Hybrid Frozen Elephant Trunk (FET). The aim of this study was to evaluate the midterm results of secondary extension of the FET by thoracic endovascular aortic repair (TEVAR). Few data are present in the literature regarding the outcomes of this secondary treatment. The investigators perform a prospective study between 2015 and 2022 in a tertiary aortic center on all consecutive patients having undergone TEVAR after FET implantation. The TEVAR endograft covered most of the 10 cm FET module with 2 to 4 mm oversizing. All patients were monitored by computerized angiography (CTA) at 6-month and yearly thereafter. The aim of this study was the feasibility of theses secondary connexion and the mid term outcomes of the endovascular treatment.

Conditions

Thoraco-abdominal Aneurysm; Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• Absence of endoleak after secondary connexion

  Absence of Type 1A endoleak

  yearly thereafter up to 5 years

Secondary Outcomes (2)

• Feasibility of the secondary connexion

  During the surgery

• Absence of endoleak after secondary connexion

  early thereafter up to 5 years

Interventions

Secondary TEVAR after initial FET procedure PROCEDURE

Under general anesthesia, via percutaneous femoral access, the investigators implant a TEVAR in the endovascular part of a FET. This secondary connexion is indicated in case distal thoracic aortic involvement such as aneurysm or dissection.

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

Patient with aortic cross replacement by FET who are indicated for a secondary connexion in emergency : Aortic type A dissection with organ malperfusion Defect in the expansion of the FET module or in chronical evolution: Type 1 and Type 2 Thoracoabdominal aneurysm (TAAA) with a diameter at \> 6 cm Aneurysmal evolution of the false lumen of a dissected aorta.

You may qualify if:

• Patient with aortic cross replacement by FET and
• Type 1 and Type 2 Thoracoabdominal aneurysm (TAAA) with a diameter at \> 6 cm or
• an aortic dissection, Type A (TAAD) or Type B (TBAD) with either organ malperfusion due to compression of the true channel or aneurysmal evolution of the dissected aorta, or
• A defect in the expansion of the FET module

You may not qualify if:

• No aortic cross replacement by FET

Sponsors & Collaborators

• University Paul Sabatier of Toulouse: lead
• Jean Porterie, MD: collaborator
• Thibaut Boisroux, MD: collaborator
• Bertrand Marcheix, MD, PhD: collaborator
• Jean Baptiste Ricco, MD, PhD: collaborator
• Xavier Chaufour, MD, PhD: collaborator

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hostalrich Aurelien, MD

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: October 7, 2022
• Study Start: January 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share