Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451484
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-04
Brief Title:
Grade Analysis of Veins by MRI and CT in Post-Thrombotic Syndrome
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Multicenter Study to Evaluate a Severity Score Using Venous MRI and CT in Patients With Post-Phlebitic Syndrome
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GrAVITSPT
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 heavinessfatigue 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None