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

NCT05954663 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2023-07-21

No results posted yet for this study

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

Conditions

  • Venous Recanalisation

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-02-01
Completion
2022-02-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05954663 on ClinicalTrials.gov