Computational Fluid Dynamics Predicting Intraprosthetic T... | NCT06701773

Studies
Computational Fluid Dynamics Predicting Intraprosthetic Thrombus Formation and Progression Following EVAR

NCT06701773

Sponsor

Xiangya Hospital of Central South University

Status

Completed

Last Update Posted

Nov 22, 2024Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Intraprosthetic Thrombus
Limb Graft Occlusion

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jun 30, 2024Actual

Completion Date

Jun 30, 2024Actual

First Submitted Date

Nov 17, 2024

First Submission Date that Met QC Criteria

Nov 20, 2024

First Posted Date

Nov 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2024

Last Update Posted Date

Nov 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Wang, Professor, Xiangya Hospital of Central South UniversityPrincipal Investigator

Lead Sponsor

Xiangya Hospital of Central South UniversityOTHER

Collaborators

Name	Class
Second Affiliated Hospital of Nanchang University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. This study aims to assess the potential of computational fluid dynamics (CFD) in predicting IPT formation and its progression to LGO after EVAR.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergone endovascular aneurysm repair.

Sampling Method

Probability Sample