AneurysmLoRETANCT03499431
Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms
An observational study of Aneurysm and Aortic Aneurysm, run by Tara Mastracci.
Trial summary
The purpose of this study is to evaluate the long-term safety and performance of complex endovascular aneurysm repair by inclusion in a longitudinal registry Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aneurysm, Aortic Aneurysm
- What is being tested?
- Endovascular Thoracoabdominal Aneurysm Repair
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2018to Mar 2023
- How long will I take part?
- 7 Years
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing complex EVAR at study sites.
Who may be able to join
- Patient eligibility for enrolment shall be based on known information at the time of the procedure. Information obtained at a later date may contradict these criteria, but this will not be considered a deviation of the Study Plan.
- A patient is deemed suitable for inclusion in the study if the patient meets both of the following criteria:
- Patient requires endovascular repair of a thoracic, thoraco-abdominal or abdominal aortic or aorto-iliac aneurysm having morphology suitable for endovascular repair with complex endograft.
- Patients (or their legal representative for minor patients) who do not object to (oral non-objection declaration, and signed consent form) collection and transmission of his/her data.
Who cannot join
- Patients are excluded from enrolment into the study if any of the following are true:
- Patients whose imaging follow-up is impossible, i.e. patients who are not able to send their follow up CT scans or Duplex US
About this study
Official title: Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms: Study of Fenestrated and Branched Stent Grafts in the Treatment of Aortic Aneurysms
The purpose of this study is to evaluate the long-term safety and performance of complex endovascular aneurysm repair by inclusion in a longitudinal registry
Read the detailed description
This is a Global, multicenter, prospective, observational, non-randomized, single-arm, open clinical study will evaluate the long term (i.e. >5 years) safety and efficacy of complex endovascular repair
This study will enroll all patients treated with Fenestrated and Branched devices in Europe and Canada that follow all inclusion criteria and none of the exclusion criteria. The total duration of the study will be of approximately 7 years.
- Conditions
- Aneurysm, Aortic Aneurysm
- Being tested
- Endovascular Thoracoabdominal Aneurysm Repair
- Medical subject headings
- Aneurysm, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Thoracoabdominal Aneurysm RepairDevice
Also called Branched and Fenestrated Devices
Standard of care, treatment of thoracoabdominal aneurysms using endovascular techiniques.
What is being measured
The primary outcome is the main question the study is designed to answer.
Longterm Aneurysm Related Mortality
Death attributed to aneurysm rupture
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start30 Apr 2018 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,000 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Tara Mastracci
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, Skane University Hospital
- Responsible party
- Sponsor-investigator, Tara Mastracci, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499431
- Sponsor's protocol ID
- 001
- Acronym
- LoRETA
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms: Study of Fenestrated and Branched Stent Grafts in the Treatment of Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03499431
- Acronym / sponsor ID
- LoRETA / 001
- Conditions
- Aneurysm, Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tara MastracciUniversity, hospital or other
- Collaborators
- University Hospital, Lille, Skane University Hospital
- Study start
- 30 Apr 2018 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 17 Apr 2018 (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.
The purpose of this study is to evaluate the long-term safety and performance of complex endovascular aneurysm repair by inclusion in a longitudinal registry
Detailed description
This is a Global, multicenter, prospective, observational, non-randomized, single-arm, open clinical study will evaluate the long term (i.e. >5 years) safety and efficacy of complex endovascular repair
This study will enroll all patients treated with Fenestrated and Branched devices in Europe and Canada that follow all inclusion criteria and none of the exclusion criteria. The total duration of the study will be of approximately 7 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing complex EVAR at study sites.
Key inclusion criteria (4 listed)
- Patient eligibility for enrolment shall be based on known information at the time of the procedure. Information obtained at a later date may contradict these criteria, but this will not be considered a deviation of the Study Plan.
- A patient is deemed suitable for inclusion in the study if the patient meets both of the following criteria:
- Patient requires endovascular repair of a thoracic, thoraco-abdominal or abdominal aortic or aorto-iliac aneurysm having morphology suitable for endovascular repair with complex endograft.
- Patients (or their legal representative for minor patients) who do not object to (oral non-objection declaration, and signed consent form) collection and transmission of his/her data.
Key exclusion criteria (2 listed)
- Patients are excluded from enrolment into the study if any of the following are true:
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 |
|---|---|---|
| Endovascular Thoracoabdominal Aneurysm RepairAlso: Branched and Fenestrated DevicesStandard of care, treatment of thoracoabdominal aneurysms using endovascular techiniques. | Device | – |
Primary outcome
Longterm Aneurysm Related Mortality
Time frame: 7 years
Death attributed to aneurysm rupture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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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 Aneurysm and Aortic Aneurysm, run by Tara Mastracci.
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 2 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 17 Apr 2018. 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?
Longterm Aneurysm Related Mortality (time frame: 7 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 17 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.