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

ConditionsDeep Vein Thrombosis of Lower LimbPostthrombotic Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWeiwei Wu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thrombosis aspiration

    Procedure/Surgery

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

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Standard anticoagulation groupNo intervention 0 interventions
Group B: Thrombosis aspiration groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
24-month post-operation

Secondary outcomes

1

Thrombosis recurrence rate

Thrombosis recurrence rate

Time frame
30 days post-operation
2

Villalta Scale

Villalta Scale 1. Scale Composition The scale consists of 5 clinical signs and 5 subjective symptoms, each rated from 0 to 3 points: 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe 1.1 Subjective Symptoms (5 items) Lower limb pain Lower limb aching and distending discomfort Lower limb heaviness Leg cramp Skin pruritus 1.2 Clinical Signs (5 items) Lower limb edema Calf skin pigmentation Subcutaneous lipodermatosclerosis / skin induration Lower limb varicose veins Skin ulceration 2. Scoring Rules Total score = Sum of scores of all 10 items Total score range: 0-30 points 3. Severity Grading Criteria (Clinically accepted, applicable for clinical trial protocol) 0-2 points: No post-thrombotic syndrome (No PTS) 3-4 points: Mild PTS 5-9 points: Moderate PTS ≥ 10 points: Severe PTS Note: If active venous ulceration is present, it is directly classified as severe PTS, regardless of the total score.

Time frame
30 days, 6 months, 12 months, and 24 months postoperatively
3

VEINES-QOL/Sym Score

Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) Scale (A total of 25 items, each scored from 1 to 5 points). The 25 items belong to the following categories: Physical Function Social Life and Daily Activities Work and Housework Emotional and Psychological Status Distress over Lower Limb Appearance Rating scale: 1. = No impact at all 2. = Mild impact 3. = Moderate impact 4. = Marked impact 5. = Severe impact Scoring Method The total score is the sum of all 25 items, ranging from 25 to 125 points. A higher score indicates a greater impact of venous disease on quality of life.

Time frame
30 days, 6 months, 12 months, and 24 months postoperatively
4

Postoperative massive hemorrhage

Postoperative massive hemorrhage

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weiwei Wu

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Sponsor institution

Source ClinicalTrials.gov

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