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

Aortic Dissection Clinical Trial

Official title:

Outcomes of Secondary Endovascular Aortic Repair After Initial Aortic Cross Replacement by a Frozen Elephant Trunk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05571930
• Other study ID #: TEVAR after THX
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2022
• Source: University Paul Sabatier of Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm, Abdominal
• Aortic Dissection

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University Paul Sabatier of Toulouse	Bertrand Marcheix, MD, PhD, Jean Baptiste Ricco, MD, PhD, Jean Porterie, MD, Thibaut Boisroux, MD, Xavier Chaufour, MD, PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of endoleak after secondary connexion	Absence of Type 1A endoleak	yearly thereafter up to 5 years
Secondary	Feasibility of the secondary connexion	Absence of failed procedure	During the surgery
Secondary	Absence of endoleak after secondary connexion	Absence of Type 3 endoleak	early thereafter up to 5 years