CHEVROPIS: Clinical and Hemodynamic Evaluation After Venous Recanalization of Post-thrombotic Iliofemoral Syndromes
Study Details
Study Description
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):
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External validation of hemodynamic criteria proposed in the literature to detect venous stent obstruction
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Risk factors for venous stent restenosis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients who underwent venous recanalization by angioplasty-stenting Patients who underwent venous recanalization by angioplasty-stenting for post-thrombotic iliofemoral syndromes from June 2014 to June 2021. |
Other: Basic demographic information
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
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Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis.
Exclusion Criteria:
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Inability to consent
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Age <18 years old
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Life expectancy <3 months
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Incomplete medical records
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Lost in follow up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupement Hospitalier Edouard Herriot | Lyon | France | 69437 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL22_1131