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

July 20, 2023 updated by: Hospices Civils de Lyon

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • Groupement Hospitalier Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Population with a disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 first month post intervention
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.
6 first month post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 26, 2022

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL22_1131

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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