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

Completed

• Conditions: Venous Recanalisation
• Interventions: Other: Basic demographic information

• Registration Number: NCT05954663
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-26
• Status Verified: 2023-07
• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-20
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who underwent venous recanalization by angioplasty-stenting	Basic demographic information	Patients who underwent venous recanalization by angioplasty-stenting for post-thrombotic iliofemoral syndromes from June 2014 to June 2021.

Primary Outcome Measures

Name	Time	Method
Clinical improvement	6 first month post intervention	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.
Stent patency	6 first month post intervention	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

Trial Locations

Locations (1)

Groupement Hospitalier Edouard Herriot; 🇫🇷 Lyon, France