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Long-Term Post Thrombotic Syndrome Assessment (CELEST Long Term).

NCT06046807 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 288

Last updated 2023-09-21

No results posted yet for this study

Summary

The CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. The primary objective is to assess the proportion of patients with moderate-severe PTS assessed with the patient reported Villalta score and the 2 main secondary objectives are to assess predictors of moderate to severe PTS and the impact of initial compression stockings strength (25mmHg vs. 35mmHg) on the development of moderate-severe PTS. Up to 288 patients may participate.

The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial compression stockings strengths on the risk of PTS.

Conditions

  • Post Thrombotic Syndrome

Interventions

OTHER

Phone call

This follow-up will be conducted over the phone and by mail (some questionnaire may be sent by patient, as per his/her preference)

Sponsors & Collaborators

  • Floralis

    collaborator INDUSTRY

  • Laboratoires Innothera

    lead INDUSTRY

Principal Investigators

  • Jean Luc Bosson, MD, PhD · University Grenoble Alpes, France

  • Jean Philippe Galanaud, MD, PhD · University of Toronto, Canada

Eligibility

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

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2023-10-24
Completion
2023-12-24

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 NCT06046807 on ClinicalTrials.gov