Grade Analysis of Veins by MRI and CT in Post-Thrombotic Syndrome (MR/CT PPS)

Multicenter Study to Evaluate a Severity Score Using Venous MRI and CT in Patients With Post-Phlebitic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Venous Thrombosis

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Chu Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients who had underwent MRI and/or phleboscan for chronic lower limb venous thrombosis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of vein severity on phleboscanner	Grade of vein severity on phleboscanner (from A-normal to D-very severe)	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: MRI; CT; multicenter study; veins; post-thrombotic syndrome; severity score
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Venous Insufficiency; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome
• Other Study ID Numbers: CHUBX 2024/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No