Thoracoabdominal Aortic AneurysmNCT06267573
Thoracoabdominal Aortic Aneurysms
An observational study of Thoracoabdominal Aortic Aneurysm, run by Assiut University.
Trial summary
Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- What is being tested?
- Fenestrated and branched endovascular devices for TAAA
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to 10 Sep 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients
Who may be able to join
- all adult consecutive patients presenting with TAAA larger than 5.5 cm
Who cannot join
- active infection Asymptomatic patients with small aneurysms Allergy to contrast agents
About this study
Official title: Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms
Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Being tested
- Fenestrated and branched endovascular devices for TAAA
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenestrated and branched endovascular devices for TAAADevice
Devices for TAAA
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful cannulation of the target vessels with complete in-line flow to target organs.
No ischemia
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startSep 2024 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Raafat Khalil Gad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267573
- Sponsor's protocol ID
- Kerolos protocol
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT06267573
- Acronym / sponsor ID
- Kerolos protocol
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 20 Feb 2024 (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.
Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients
Key inclusion criteria (1 listed)
- all adult consecutive patients presenting with TAAA larger than 5.5 cm
Key exclusion criteria (1 listed)
- active infection Asymptomatic patients with small aneurysms Allergy to contrast agents
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 |
|---|---|---|
| Fenestrated and branched endovascular devices for TAAADevices for TAAA | Device | – |
Primary outcome
Successful cannulation of the target vessels with complete in-line flow to target organs.
Time frame: Two years
No ischemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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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 Thoracoabdominal Aortic Aneurysm, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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?
Results are not available in the source record.
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?
Successful cannulation of the target vessels with complete in-line flow to target organs. (time frame: Two 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 20 Feb 2024.