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

NCT ID: NCT05571930

Last Updated: 2022-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Thoraco-abdominal Aneurysm Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Secondary TEVAR after initial FET 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No aortic cross replacement by FET
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jean Porterie, MD

UNKNOWN

Sponsor Role collaborator

Thibaut Boisroux, MD

UNKNOWN

Sponsor Role collaborator

Bertrand Marcheix, MD, PhD

UNKNOWN

Sponsor Role collaborator

Jean Baptiste Ricco, MD, PhD

UNKNOWN

Sponsor Role collaborator

Xavier Chaufour, MD, PhD

UNKNOWN

Sponsor Role collaborator

University Paul Sabatier of Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Aurélien Hostalrich

Hostalrich Aurelien, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TEVAR after THX

Identifier Type: -

Identifier Source: org_study_id

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