Clinical and Hemodynamic Evaluation After Venous Recanalization of Post-thrombotic Iliofemoral Syndromes

Study Overview
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Brief Summary
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Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT). The endovascular recanalization and stenting technique has become the gold standard treatment for medically resistant and disabling PTS. Stent thrombosis is a significant complication of this procedure; the risk factors for thrombosis are poorly understood. Monitoring the patency of the stent is a key component in maintaining clinical success. Doppler ultrasound is the first-line diagnostic tool for monitoring patients with venous stents, and has the potential to allow accurate assessment of venous stent obstruction. Absence of validated morphological and hemodynamic echodoppler criteria for the follow-up of these stents. • Main objective: Clinical and hemodynamic results of venous recanalisations by stenting in the chronic phase • Secondary objective (s): External validation of hemodynamic criteria proposed in the literature to detect venous stent obstruction Risk factors for venous stent restenosis

Official Title
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Clinical and Hemodynamic Evaluation After Venous Recanalization of Post-thrombotic Iliofemoral Syndromes

Conditions
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Venous Recanalisation

Intervention / Treatment
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* Other: Basic demographic information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis. Exclusion Criteria: Inability to consent Age <18 years old Life expectancy <3 months Incomplete medical records Lost in follow up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who underwent venous recanalization by angioplasty-stenting<br>Patients who underwent venous recanalization by angioplasty-stenting for post-thrombotic iliofemoral syndromes from June 2014 to June 2021. | Other: Basic demographic information<br>* Basic demographic information: age, sex, weight, height, BMI. Comorbidities: history of major bleeding, cardiovascular comorbidities, diabetes mellitus, renal failure, smoking, hormone therapy Anticoagulant and antiplatelet therapy (molecule, duration and indication, before and after intervention) Procedure data: number and type of stents implanted, diameters and lengths, name of stented venous segments Postoperative complications: bleeding complications, pelvic pain, early thrombosis, early pulmonary embolism Clinical examination carried out 1 month after the operation and more than 6 months after the operation Data from the control ultrasound performed 1 month after the operation and more than 6 months after the operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Villalta score Score ≤ 4: No TPS. Score between 5 and 14: mild TPS. Score between 10-14: moderate TPS. Score ≥ 15 or ulcer present: severe TPS. | 6 first month post intervention | 
| Stent patency | Analyze of venous patency of each venous segment Maximum peak flow velocity (in centimetres per second) at each venous segment Location of the implanted stents Cranial and caudal extremity Total length Diameter | 6 first month post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep vein thrombosisA, Endovascular recanalization and stenting, Post-thrombotic syndrome, Morphological and hemodynamic echodoppler criteria, Venous stent restenosis