Grade Analysis of Veins by MRI and CT in Post-Thrombotic Syndrome

Recruiting

• Conditions: Lower Limb Venous Thrombosis

• Registration Number: NCT06451484
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

The aim is to improve the diagnosis of chronic lower limb venous thrombosis before a lower limb venous recanalization procedure. Additionally, if the MRI scores are comparable to those of the CT, MRI would reduce radiation exposure and limit the need for foot vein punctures that accompany CT use.

Detailed Description

Endovascular management of post-thrombotic syndrome (PTS) has created new opportunities for patients and interventional radiologists. PTS is the most chronic complication of deep vein thrombosis (DVT), occurring in 20% to 40% of patients despite optimal anticoagulant therapy within the first 1 to 2 years after a lower limb DVT. PTS is characterized by various symptoms lasting more than 6 months after a DVT, including mild pain or swelling, venous claudication, heaviness/fatigue, chronic pain or cramps, venous ulcers, edema, skin discoloration, and venous ectasia. Severe PTS negatively impacts quality of life. Several clinical tools or scales, such as the Villalta scale and CIVIQ-20, are used to diagnose and define PTS. Endovascular treatment of symptomatic chronic iliofemoral vein occlusions has shown good technical and clinical efficacy, with significant clinical benefits and improvements in the Villalta and CIVIQ scores. Proper planning of the recanalization procedure is essential, using CT and MRI imaging to analyze the venous anatomy in the pelvis, abdomen, and lower limbs. The CT is the reference examination for chronic lower limb thrombosis, performed using the Baldt technique to opacify the deep venous network and detect endoluminal adhesions. However, there are risks such as failure to puncture the veins on the back of the foot, pain during puncture, and flow artifacts. MRI is less commonly used due to its availability and long examination times, but its results are promising. The literature on chronic lower limb thrombosis is limited, with no consensus on lesion descriptions, highlighting the need for a descriptive lesion score

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-11
• Study Start: 2024-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Men and women aged more than 18 years old,
• patient's oral consent,
• affiliated or beneficiary of health insurance

Exclusion Criteria

• inability of the patient to understand the nature or risks or significance and implications of the clinical investigation,
• patient under legal protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grade of vein severity on phleboscanner	Baseline	Grade of vein severity on phleboscanner (from A-normal to D-very severe)

Secondary Outcome Measures

Name	Time	Method
Grade of vein severity on MRI	Baseline	Grade of vein severity on MRI(from A-normal to D-very severe)
Inter-observator reproducibility on MRI	Baseline	Intra-class correlation coefficient
Inter-observator reproducibility on phleboscan	Baseline	Intra-class correlation coefficient
Reproducibility between MRI and phleboscan	Baseline	Intra-class correlation coefficient

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeaux, France