Thoraco-abdominal AneurysmNCT05571930
Outcomes of Secondary Endovascular Aortic Repair After Initial Frozen Elephant Trunk Procedure
An observational study of Thoraco-abdominal Aneurysm and Aortic Dissection, run by University Paul Sabatier of Toulouse.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoraco-abdominal Aneurysm, Aortic Dissection
- What is being tested?
- Secondary TEVAR after initial FET procedure
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No aortic cross replacement by FET
About this study
Official title: Outcomes of Secondary Endovascular Aortic Repair After Initial Aortic Cross Replacement by a Frozen Elephant Trunk
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
- Being tested
- Secondary TEVAR after initial FET procedure
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary TEVAR after initial FET procedureProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of endoleak after secondary connexion
Absence of Type 1A endoleak
Measured: yearly thereafter up to 5 years
Secondary outcomes (2)
Feasibility of the secondary connexion
Absence of failed procedure
Measured: During the surgery
Absence of endoleak after secondary connexion
Absence of Type 3 endoleak
Measured: early thereafter up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Jan 2015
- Primary completion1 Jan 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoraco-abdominal AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Jean Porterie, MD, Thibaut Boisroux, MD, Bertrand Marcheix, MD, PhD, Jean Baptiste Ricco, MD, PhD, Xavier Chaufour, MD, PhD
- Responsible party
- Principal investigator, Aurélien Hostalrich, University Paul Sabatier of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571930
- Sponsor's protocol ID
- TEVAR after THX
- Status last verified
- Oct 2022
- First submitted
- 24 May 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are anonymised in our local prospective database shared between all investigators.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Secondary Endovascular Aortic Repair After Initial Aortic Cross Replacement by a Frozen Elephant Trunk
- ClinicalTrials.gov ID
- NCT05571930
- Acronym / sponsor ID
- TEVAR after THX
- Conditions
- Thoraco-abdominal Aneurysm, Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Collaborators
- Jean Porterie, MD, Thibaut Boisroux, MD, Bertrand Marcheix, MD, PhD, Jean Baptiste Ricco, MD, PhD, Xavier Chaufour, MD, PhD
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No aortic cross replacement by FET
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary TEVAR after initial FET procedureUnder 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. | Procedure or surgery | – |
Primary outcome
Absence of endoleak after secondary connexion
Time frame: yearly thereafter up to 5 years
Absence of Type 1A endoleak
2 secondary outcomes
Feasibility of the secondary connexion
Time frame: During the surgery
Absence of endoleak after secondary connexion
Time frame: early thereafter up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No. Data are anonymised in our local prospective database shared between all investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoraco-abdominal Aneurysm and Aortic Dissection, run by University Paul Sabatier of Toulouse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of endoleak after secondary connexion (time frame: yearly thereafter up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.