Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction

Not Applicable

Terminated

• Conditions: Deep-Venous Thrombosis; Deep Venous Stenting; Randomized Clinical Trial
• Interventions: Device: deep venous stenting

• Registration Number: NCT03026049
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Patients will be randomised between deep venous stenting or conservative management

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Study Start: 2017-03-09
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deep venous stent	deep venous stenting	Patients will receive deep venous stenting in the iliaco(femoral) region

Primary Outcome Measures

Name	Time	Method
Quality of Life score	12 months	Quality of Life score

Trial Locations

Locations (1)

Maastricht university medical center; 🇳🇱 Maastricht, Limburg, Netherlands