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

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

Completed

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Key information

Conditions

Venous Recanalisation Cardiovascular Diseases Embolism and Thrombosis Postthrombotic Syndrome Thrombosis Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupement Hospitalier Edouard Herriot

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basic demographic information

Other

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

Primary outcomes

Clinical improvement

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: CHEVROPIS

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jul 20, 2023
Registry last updated: Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed