Aortic Aneurysm AbdominalRegisTREONCT06893952
Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms
An observational study of Aortic Aneurysm Abdominal, run by Vascutek Ltd..
Trial summary
This study is a clinical investigation as part of the post-market clinical follow-up of the TREO® abdominal aortic graft in its initial use, French, observational, multicenter, non-randomized, single-arm. Information on patient's health and the implanted device will be collected over a period of 5 consecutive years. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Aortic Aneurysm Abdominal
- What is being tested?
- TREO Endograft
- Type of treatment
- Medical device
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with: * an asymptomatic infrarenal abdominal aortic aneurysm with a largest diameter greater than 5.5 cm in men and 5 cm in women or if the diameter increases by 1 cm in 1 year (for an aneurysm with a diameter greater than 4 cm). * a symptomatic infrarenal abdominal aortic aneurysm, regardless of the size.
Who may be able to join
- Patient who has confirmed his/her non-opposition to the use of his/her data in the study.
- Patient aged 45 years or older.
- Patient with AAA with one of the following criteria:
- Maximum diameter ≥50 mm for women and ≥55 mm for men
- Rapid growth (≥5 mm in 6 months or ≥10 mm in 12 months)
- Unruptured AAA with clinical symptoms of abdominal pain
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- Adequate anatomy for TREO® stent graft implantation, including:
- Adequate iliac and femoral arteries for the modular system
- Suprarenal angle less than 45 degrees
- Infrarenal aortic neck greater than or equal to 10 mm in length with an angle less than 60° and an internal diameter of 17mm-32mm, or an infrarenal aortic neck greater than or equal to 15 mm in length with an angle between 60 and 75° and an internal diameter of 16mm-30mm
- Distal iliac sealing distance ≥ 10 mm and an iliac diameter between 8-13 mm or a distal iliac sealing distance ≥ 15 mm and a diameter between 13-21 mm
- Ability to follow the entire protocol from 1 to 60 months
- Life expectancy greater than 2 years
Who cannot join
- Patients refusing treatment and follow-up as part of the study
- Infected or ruptured aneurysm
- Associated aortic lesion (thoracic or thoracoabdominal aneurysm) requiring management
- Renal failure defined by creatinine > 2.5 mg/dL or patient in pre-dialysis status and impossibility of intervention with use of CO2 injection
- New York Heart Association (NYHA) class IV
- Aneurysmal, dissected distal implantation zone, or including calcifications and/or significant thrombus that could compromise sealing
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- Tortuous iliac and/or femoral access and/or including calcified stenosis
- Systemic infection that could increase the risk of infection of the endoprosthesis
- Pathology of the supporting tissues such as collagenosis (Marfan or Ehler-Danlos, etc.)
- Known drug use
- Known sensitivity or allergy to the materials to be implanted
- Patients contraindicated for antiplatelet treatment
- Patients with an uncontrolled hematological disorder or heparin-induced thrombocytopenia
- Patients who are pregnant or planning to become pregnant
- Patients considered hemodynamically unstable or requiring emergency treatment
- Patients with severe arterial disease leading to a negative "outflow" that may degrade the permeability of implanted stents
- Scheduled hybrid aortic technique (surgical and endovascular)
- Patients with complex iliac access outside the manufacturer's indications and recommendations that may lead to procedural failure
About this study
This study is a clinical investigation as part of the post-market clinical follow-up of the TREO® abdominal aortic graft in its initial use, French, observational, multicenter, non-randomized, single-arm. Information on patient's health and the implanted device will be collected over a period of 5 consecutive years. The data collected will be analyzed on the technical success and the absence of major events (death, stroke, myocardial infarction, visceral ischemia, paraplegia, respiratory failure, renal failure, intraoperative blood loss, thromboembolic event) and possible reinterventions related to the patient's operation.
- Conditions
- Aortic Aneurysm Abdominal
- Being tested
- TREO Endograft
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREO EndograftDevice
Post Market collection data in use of TREO modular endografts
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes of this study are the rate of a composite measure of technical and clinical success at 1 and 12 months to assess efficacy, and the rate of a composite measure of free from major adverse events at 1 month to assess safety.
Definition of the composite of technical success:
- Successful access to the arterial system using remote arterial exposure, percutaneous technique, surgical access, or open surgical conduits.
- Successful delivery and deployment of all components of the modular stent graft.
- Absence of type I or type III endoleaks at the end of angiography that extend beyond 30 days confirmed by imaging*.
- Patency of all components of the modular stent graft.
Definition of the composite of clinical success :
- Technical success
- No death during the initial procedure, related to the procedure or from aortic-related causes during the initial hospitalization
- No type I and III endoleaks, at 1 and 12 months
- No early migration (> 10 mm), at 1 and 12 months
- No increase in maximum sac diameter of more than 5 mm between 1 and 12 months
- No aneurysm rupture, at 1 and 12 months
- No surgical conversion related to aneurysm treatment, at 1 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm AbdominalStudies 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
- 209 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893952
- Sponsor's protocol ID
- RegisTREO _2024.01
- Acronym
- RegisTREO
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT06893952
- Acronym / sponsor ID
- RegisTREO / RegisTREO _2024.01
- Conditions
- Aortic Aneurysm Abdominal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 25 Mar 2025 (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.
This study is a clinical investigation as part of the post-market clinical follow-up of the TREO® abdominal aortic graft in its initial use, French, observational, multicenter, non-randomized, single-arm. Information on patient's health and the implanted device will be collected over a period of 5 consecutive years. The data collected will be analyzed on the technical success and the absence of major events (death, stroke, myocardial infarction, visceral ischemia, paraplegia, respiratory failure, renal failure, intraoperative blood loss, thromboembolic event) and possible reinterventions related to the patient's operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with: * an asymptomatic infrarenal abdominal aortic aneurysm with a largest diameter greater than 5.5 cm in men and 5 cm in women or if the diameter increases by 1 cm in 1 year (for an aneurysm with a diameter greater than 4 cm). * a symptomatic infrarenal abdominal aortic aneurysm, regardless of the size.
Key inclusion criteria (13 listed)
- Patient who has confirmed his/her non-opposition to the use of his/her data in the study.
- Patient aged 45 years or older.
- Patient with AAA with one of the following criteria:
- Adequate anatomy for TREO® stent graft implantation, including:
- Ability to follow the entire protocol from 1 to 60 months
Key exclusion criteria (18 listed)
- Patients refusing treatment and follow-up as part of the study
- Infected or ruptured aneurysm
- Associated aortic lesion (thoracic or thoracoabdominal aneurysm) requiring management
- Renal failure defined by creatinine > 2.5 mg/dL or patient in pre-dialysis status and impossibility of intervention with use of CO2 injection
- New York Heart Association (NYHA) class IV
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 |
|---|---|---|
| TREO EndograftPost Market collection data in use of TREO modular endografts | Device | – |
Primary outcome
The primary outcomes of this study are the rate of a composite measure of technical and clinical success at 1 and 12 months to assess efficacy, and the rate of a composite measure of free from major adverse events at 1 month to assess safety.
Time frame: 12 months
Definition of the composite of technical success: * Successful access to the arterial system using remote arterial exposure, percutaneous technique, surgical access, or open surgical conduits. * Successful delivery and deployment of all components of the modular stent graft. * Absence of type I or type III endoleaks at the end of angiography that extend beyond 30 days confirmed by imaging*. * Patency of all components of the modular stent graft. Definition of the composite of clinical success : * Technical success * No death during the initial procedure, related to the procedure or from aortic-related causes during the initial hospitalization * No type I and III endoleaks, at 1 and 12 months * No early migration (> 10 mm), at 1 and 12 months * No increase in maximum sac diameter of more than 5 mm between 1 and 12 months * No aneurysm rupture, at 1 and 12 months * No surgical conversion related to aneurysm treatment, at 1 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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.
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 Aortic Aneurysm Abdominal, run by Vascutek Ltd..
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 13 inclusion and 18 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: opening soon, as of the sponsor's last update on 25 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary outcomes of this study are the rate of a composite measure of technical and clinical success at 1 and 12 months to assess efficacy, and the rate of a composite measure of free from major adverse events at 1 month to assess safety. (time frame: 12 months). 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 25 Mar 2025.