Computational Fluid Dynamics Predicting Intraprosthetic Thrombus Formation and Progression Following EVAR

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.

Study Overview

• Status: Completed
• Conditions: Intraprosthetic Thrombus; Limb Graft Occlusion

• Study Type: Observational
• Enrollment (Actual): 72

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients undergone endovascular aneurysm repair.

Description

Inclusion Criteria:

1. Aged 18 and above;
2. Patients undergone endovascular aneurysm repair;
3. Signed informed consent forms, willing to receive treatments.

Exclusion Criteria:

1. inflammatory aortic aneurysm;
2. patients diagnosed with connective tissue diseases;
3. patients diagnosed with atrial fibrillation;
4. patients lacking post-operative CTA;
5. Patients who are participating in other clinical projects;
6. Patients are not suitable to participate in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of intraprosthetic thrombus in limb graft	Evaluate the area of thrombus occupying the lumen using postoperative CTA	From January 2014 to June 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-related complications	Disease-related complications associated with intraprosthetic thrombus or limb graft occlusion, such as thromboembolic events	From January 2014 to June 2024

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Collaborators: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 2024030373

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No