Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction (STEVECO)

Maastricht University Medical Centre (MUMC)

Status: Terminated

Conditions: Deep-Venous Thrombosis; Randomized Clinical Trial; Deep Venous Stenting

Treatments: Device: deep venous stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT03026049

RCT DVO

Details and patient eligibility

About

Patients will be randomised between deep venous stenting or conservative management

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

deep venous stent

Active Comparator group

Description:

Patients will receive deep venous stenting in the iliaco(femoral) region

Treatment:

Device: deep venous stenting

conservative managment

No Intervention group

Description:

Conservative management of complaints