Clinical trial NCT06451484: Grade Analysis of Veins by MRI and CT in Post-Thrombotic Syndrome
Official title: Multicenter Study to Evaluate a Severity Score Using Venous MRI and CT in Patients With Post-Phlebitic Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Limb Venous Thrombosis
Keywords: post-thrombotic syndrome
CT
veins
MRI
severity score
multicenter study
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had underwent MRI and/or phleboscan for chronic lower limb venous thrombosis

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

Eligibility criteria: 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

Primary outcomes:
measure: Grade of vein severity on phleboscanner
timeFrame: Baseline
Secondary outcomes:
measure: Grade of vein severity on MRI
timeFrame: Baseline
measure: Inter-observator reproducibility on MRI
timeFrame: Baseline
measure: Inter-observator reproducibility on phleboscan
timeFrame: Baseline
measure: Reproducibility between MRI and phleboscan
timeFrame: Baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: