Comparing ClotTriever vs. aspiration thrombectomy for acute iliofemoral DVT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study compares two mechanical thrombectomy approaches in adults with acute iliofemoral DVT. Participants receive either the ClotTriever System or an aspiration/rheolytic thrombectomy technique as part of endovascular treatment. The goal is to see if the ClotTriever improves thrombus removal, lowers the risk of post-thrombotic syndrome, and enhances long-term outcomes after treatment. Data will be collected across participating hospitals to observe real-world effectiveness and safety. The study does not assign treatments but observes current clinical practice at participating centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged between 18 and 85 years;
2. Diagnosed with acute iliofemoral venous thrombosis, with thrombosis involving at least the iliac vein and common femoral vein;
3. Time from symptom onset to endovascular treatment ≤ 14 days;
4. Patients undergo endovascular treatment with percutaneous mechanical thrombectomy;
5. Patients sign the informed consent form.

Exclusion Criteria:

1. Presence of PTS in the limb to be treated in this procedure, or a history of symptomatic DVT in the same limb within the past 2 years;
2. Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
3. Known allergy to heparin, low molecular weight heparin, contrast agents, etc.
4. Concomitant severe pulmonary embolism with hemodynamic changes, such as hypoxia, hypotension, etc.
5. Inability to tolerate endovascular treatment due to conditions such as acute systemic illness, severe dyspnea, etc.
6. Concomitant severe renal insufficiency with creatinine clearance \< 30 ml/min;
7. Concomitant active bleeding, severe hepatic insufficiency, bleeding tendency, etc.
8. Concomitant severe anemia (hemoglobin \< 8.0 mg/dL) or platelet count \< 80,000/mL;
9. History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm;
10. Pregnant women;
11. Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency, etc.) with an expected life expectancy \< 24 months
12. Participation in any drug or medical device clinical trial that may interfere with this study within the past 1 month;
13. Patients unwilling to participate in this trial.

Where it's running

• Renji hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Qihong Ni
• Email: niqihong1989@163.com
• Phone: +8615801900772

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.