NCT03026049
Terminated
Not Applicable
A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction
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
Investigators
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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