Intraprosthetic ThrombusNCT06701773
Computational Fluid Dynamics Predicting Intraprosthetic Thrombus Formation and Progression Following EVAR
An observational study of Intraprosthetic Thrombus and Limb Graft Occlusion, run by Xiangya Hospital of Central South University.
Trial summary
Intraprosthetic thrombus (IPT) formation and its progression to limb graft occlusion (LGO) are significant complications following endovascular aneurysm repair (EVAR). Morphological metrics based on preoperative CTA have limited predictive value for these complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraprosthetic Thrombus, Limb Graft Occlusion
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergone endovascular aneurysm repair.
Who may be able to join
- Aged 18 and above;
- Patients undergone endovascular aneurysm repair;
- Signed informed consent forms, willing to receive treatments.
Who cannot join
- inflammatory aortic aneurysm;
- patients diagnosed with connective tissue diseases;
- patients diagnosed with atrial fibrillation;
- patients lacking post-operative CTA;
- Patients who are participating in other clinical projects;
- Patients are not suitable to participate in this study.
About this study
Official title: Computational Fluid Dynamics Predicting Intraprosthetic Thrombus Formation and Progression Following Endovascular Aortic Repair: a Two-center Retrospective Study
Intraprosthetic thrombus (IPT) formation and its progression to limb graft occlusion (LGO) are significant complications following endovascular aneurysm repair (EVAR). Morphological metrics based on preoperative CTA have limited predictive value for these complications. This study aims to assess the potential of computational fluid dynamics (CFD) in predicting IPT formation and its progression to LGO after EVAR.
- Conditions
- Intraprosthetic Thrombus, Limb Graft Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intraprosthetic thrombus Group | presence of intraprosthetic thrombus according to the postoperative CTA | |
| Non-intraprosthetic thrombus Group | absence of intraprosthetic thrombus according to the postoperative CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of intraprosthetic thrombus in limb graft
Evaluate the area of thrombus occupying the lumen using postoperative CTA
Measured: From January 2014 to June 2024
Secondary outcomes (1)
Disease-related complications
Disease-related complications associated with intraprosthetic thrombus or limb graft occlusion, such as thromboembolic events
Measured: From January 2014 to June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Jan 2014
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraprosthetic ThrombusStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Wei Wang, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701773
- Sponsor's protocol ID
- 2024030373
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Fluid Dynamics Predicting Intraprosthetic Thrombus Formation and Progression Following Endovascular Aortic Repair: a Two-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06701773
- Acronym / sponsor ID
- 2024030373
- Conditions
- Intraprosthetic Thrombus, Limb Graft Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Nanchang University
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Nov 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.
Intraprosthetic thrombus (IPT) formation and its progression to limb graft occlusion (LGO) are significant complications following endovascular aneurysm repair (EVAR). Morphological metrics based on preoperative CTA have limited predictive value for these complications. This study aims to assess the potential of computational fluid dynamics (CFD) in predicting IPT formation and its progression to LGO after EVAR.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraprosthetic thrombus Group | – | –presence of intraprosthetic thrombus according to the postoperative CTA |
| Non-intraprosthetic thrombus Group | – | –absence of intraprosthetic thrombus according to the postoperative CTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergone endovascular aneurysm repair.
Key inclusion criteria (3 listed)
- Aged 18 and above;
- Patients undergone endovascular aneurysm repair;
- Signed informed consent forms, willing to receive treatments.
Key exclusion criteria (6 listed)
- inflammatory aortic aneurysm;
- patients diagnosed with connective tissue diseases;
- patients diagnosed with atrial fibrillation;
- patients lacking post-operative CTA;
- Patients who are participating in other clinical projects;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of intraprosthetic thrombus in limb graft
Time frame: From January 2014 to June 2024
Evaluate the area of thrombus occupying the lumen using postoperative CTA
1 secondary outcome
Disease-related complications
Time frame: From January 2014 to June 2024
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 22 Nov 2024.
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 Intraprosthetic Thrombus and Limb Graft Occlusion, run by Xiangya Hospital of Central South 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 3 inclusion and 6 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 22 Nov 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?
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?
Degree of intraprosthetic thrombus in limb graft (time frame: From January 2014 to June 2024). 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 22 Nov 2024.