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

NCT07573618 | Not Yet Recruiting DMC

• 1 other identifier: 26439-4-01
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Deep Vein Thrombosis of Lower Limb; Postthrombotic Syndrome

Outcome Measures

Primary Outcomes (1)

• Postoperative hierarchical composite endpoint at 24 months.

  This trial employs a superiority design using the win ratio method for the hierarchical composite endpoint of primary efficacy. The hierarchical composite endpoint indicators are, in order: in-hospital death or treatment escalation, recurrent venous thrombosis of the target lesion or new-onset pulmonary embolism within 24 months, severity of the Villalta scale at 24 months, and change in the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms (VEINES--QOL/Sym）score at 24 months.

  24-month post-operation

Secondary Outcomes (5)

• Thrombosis recurrence rate

  30 days post-operation

• Villalta Scale

  30 days, 6 months, 12 months, and 24 months postoperatively

• VEINES-QOL/Sym Score

  30 days, 6 months, 12 months, and 24 months postoperatively

• Postoperative massive hemorrhage

  30 days

• Immediate Postoperative Thrombus Clearance Success Rate (Experimental Group Only)

  Immediately after procedure

Study Arms (2)

Standard anticoagulation group

NO INTERVENTION

only standard anticoagulant therapy

Thrombosis aspiration group

EXPERIMENTAL

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

Procedure: Thrombosis aspiration

Interventions

Thrombosis aspiration PROCEDURE

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

Thrombosis aspiration group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weiwei Wu: lead

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Vascular Surgery Department

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2030
• Last Updated: May 7, 2026

Record last verified: 2026-05