Preservation of Venous Valvular Function After PMT for Acute DVT

Study Overview
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Brief Summary
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To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.

Detailed Description
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All patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via AngioJet devices or anticoagulation alone were included in this study.

Official Title
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Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study

Conditions
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Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Intervention / Treatment
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* Device: AngioJet device
* Other: anticoagulation alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific). Exclusion Criteria: Participants were excluded if they had symptoms for more than 14 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacomechanical Catheter-directed Thrombolysis for acute DVT<br>AngioJet, Boston Scientific | Device: AngioJet device<br>* A device can be used for thrombus aspiration and thrombolysis.<br>* Other names: Zalente;|
| Placebo Comparator: anticoagulation alone for acute DVT<br>anticoagulation alone for acute DVT | Other: anticoagulation alone<br>* a medicine for anticoagulation therapy<br>* Other names: rivaroxaban;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valvular reflux prevalence | Proportion of patients with femoral venous valve reflux at 1 year after procedure | at 12 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) | Patients who experienced one of the following occurrences in the index leg between the 12 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse. | at 6, 12 and 24 months after procedure | 
| Patency rate of femopopliteal vein and iliofemoral vein | Patients who presented with patent femopopliteal vein and iliofemoral vein | at 6, 12 and 24 months after procedure |