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NCT07573618

Acute or Subacute Iliofemoral Vein Thrombosis: Aspiration for Flow Restoration Versus Standard Anticoagulation

Sponsor: Weiwei Wu

View on ClinicalTrials.gov

Summary

This trial is a prospective, multicenter, randomized controlled, superiority study. According to the inclusion and exclusion criteria for clinical research subjects, 104 patients with acute deep vein thrombosis involving the iliac and femoral veins were recruited. Qualified subjects were randomly (1:1) assigned to either the experimental group or the control group. The experimental group received thrombus aspiration, with or without balloon dilation, stent implantation, and other accompanying surgical treatments, combined with standard anticoagulant therapy, while the control group received only standard anticoagulant therapy. The efficacy and safety of the experimental group in treating acute iliac and femoral vein thrombosis were compared. The main efficacy endpoint of this study is the 24 month postoperative composite endpoint, with the following hierarchical order: 1. in-hospital mortality or treatment upgrade; 2. Recurrent venous thrombosis or newly developed pulmonary embolism of the target lesion within 24 months; 3. Severity of Villalta score at 24 months; 4. Change in VEINES score after 24 months. Simultaneously observe other secondary efficacy endpoints and safety endpoints. Clinical follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery, 12 months after surgery, and 24 months after surgery.

Official title: Vascular Surgery Department of Beijing Tsinghua ChangGung Hospital

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-05-01

Completion Date

2030-04-30

Last Updated

2026-05-07

Healthy Volunteers

Conditions

Deep Vein Thrombosis of Lower Limb Postthrombotic Syndrome

Interventions

PROCEDURE

Thrombosis aspiration

Thrombus aspiration, with or without balloon dilation, stent implantation, and other accompanying surgical treatments, combined with standard anticoagulant therapy

Inclusion Criteria: * Age 18-80, gender unrestricted; * Diagnosed as acute or subacute proximal deep venous thrombosis of the lower extremities through lower extremity venous ultrasound or enhanced CT of the lower extremity veins, with involvement of at least the common iliac vein, external iliac vein, or common femoral vein; * The subjects met the criteria for standard anticoagulation therapy combined with thrombus aspiration along with standard anticoagulation therapy; * The patient fully understands and voluntarily signs a written informed consent form; * Willing and able to comply with all the visit, treatment, and assessment procedures specified in the study protocol. Exclusion Criteria: * Bilateral deep iliofemoral vein thrombosis; * Femoral edema or femoral white swelling; * Inferior vena cava thrombosis; * History of deep vein thrombosis with a diagnosis of moderate to severe post-thrombotic syndrome; * The affected limb has previously had a venous stent implanted; * There are anatomical abnormalities affecting the intervention pathway, such as hypoplasia or dysplasia of the inferior vena cava, or other malformations of the iliac or inferior vena cava; * Presence of active major bleeding or clinically significant bleeding risk (hemoglobin \<80g/L or platelet count \<50×109/L); * Severe coagulation dysfunction, with an international normalized ratio \>1.7; * Uncontrolled severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg after medication); * Severe renal impairment, with a glomerular filtration rate \<30 mL/min/1.73m²; * Any interventional treatment for the target deep vein thrombosis within 30 days prior to enrollment; * Female patients in pregnancy or lactation; * Known history of allergies to drugs used during the study (such as contrast agents, anticoagulants, etc.); * Active malignant tumor; * In the judgment of the researchers, there are any other comorbidities, conditions, or poor adherence that may affect the study evaluation or place the patient at high risk.