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Clinical Trials/NCT03026049
NCT03026049
Terminated
Not Applicable

A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction

Maastricht University Medical Center1 site in 1 country65 target enrollmentMarch 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep-Venous Thrombosis
Sponsor
Maastricht University Medical Center
Enrollment
65
Locations
1
Primary Endpoint
Quality of Life score
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

Patients will be randomised between deep venous stenting or conservative management

Registry
clinicaltrials.gov
Start Date
March 9, 2017
End Date
October 7, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \>18 years
  • Meet criteria for PTS or
  • Patients with May Thurner syndrome on additional imaging
  • Life expectancy of more than one year
  • Deep venous thrombosis \> 1 year
  • Signed informed consent

Exclusion Criteria

  • Previous intervention of central veins (inferior vena cava, iliac veins, common femoral vein) on the affected limb
  • Known pregnancy
  • Inability to answer Dutch QoL questionnaires or limited communication in Dutch (written and spoken)
  • Contra-indication for prolonged anticoagulant treatment
  • Recent, \<1 year, deep venous thrombosis or pulmonary Embolism
  • Known contrast allergy
  • Known dialysis or renal insufficiency needing additional preparation for injection of contrast

Outcomes

Primary Outcomes

Quality of Life score

Time Frame: 12 months

Quality of Life score

Study Sites (1)

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