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

June 17, 2025 updated by: University Hospital, Bordeaux

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Grade of vein severity on phleboscanner
Time Frame: Baseline
Grade of vein severity on phleboscanner (from A-normal to D-very severe)
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grade of vein severity on MRI
Time Frame: Baseline
Grade of vein severity on MRI(from A-normal to D-very severe)
Baseline
Inter-observator reproducibility on MRI
Time Frame: Baseline
Intra-class correlation coefficient
Baseline
Inter-observator reproducibility on phleboscan
Time Frame: Baseline
Intra-class correlation coefficient
Baseline
Reproducibility between MRI and phleboscan
Time Frame: Baseline
Intra-class correlation coefficient
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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