Acute Deep Venous Thrombosis of Femoral Vein (Disorder)
Conditions
Brief summary
To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.
Detailed description
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.
Interventions
DEVICEAngioJet device
A device can be used for thrombus aspiration and thrombolysis.
OTHERanticoagulation alone
a medicine for anticoagulation therapy
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Valvular reflux prevalence | at 12 months after procedure | Proportion of patients with femoral venous valve reflux at 1 year after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) | at 6, 12 and 24 months after procedure | 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. |
| Patency rate of femopopliteal vein and iliofemoral vein | at 6, 12 and 24 months after procedure | Patients who presented with patent femopopliteal vein and iliofemoral vein |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORKaichuang Ye, MD, PhD
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Outcome results
None listed