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Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome (ETERecaVSPT)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Claudication, Intermittent
Post Thrombotic Syndrome
Venous Thromboses

Treatments

Diagnostic Test: Stress test

Study type

Interventional

Funder types

Other

Identifiers

NCT05794932
RECHMPL22_0560

Details and patient eligibility

About

Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient eligible for endovascular treatment for post-thrombotic syndrome in a chronic context (6 months after the occurrence of thrombosis, without time limit), after validation of the indication during a monthly medical-radiological PCR (St Eloi vascular medicine team and vascular radiologist performing the endovascular treatment)
  • Age >= 18 years

Exclusion criteria

  • Contraindication to the performance of a maximal effort test on a cyclo-ergometer
  • Refusal of consent after information
  • Adult protected by law (guardianship, curatorship)
  • Pregnant or breastfeeding woman
  • Patient not affiliated to a social security system or not benefiting from such a system

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Stress test
Experimental group
Description:
All patients will undergo a stress test before and after venous recanalization.
Treatment:
Diagnostic Test: Stress test

Trial contacts and locations

1

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Central trial contact

Valérie MONNIN-BARES, MD

Data sourced from clinicaltrials.gov

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