Acute or Subacute Iliofemoral Vein Thrombosis: Aspiration for Flow Restoration Versus Standard An… (NCT07573618) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acute or Subacute Iliofemoral Vein Thrombosis: Aspiration for Flow Restoration Versus Standard Anticoagulation
104 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative hierarchical composite endpoint at 24 months.