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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06451484

Acronym

MR/CT PPS

Enrollment

Registered

2024-06-11

Start date

2024-10-30

Completion date

2025-05-08

Last updated

2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Venous Thrombosis

Keywords

post-thrombotic syndrome, CT, veins, MRI, severity score, multicenter study

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results