Actively Recruiting
Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis (The COMET Study)
Led by RenJi Hospital · Updated on 2026-06-03
180
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
C
Changhai Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two different devices for percutaneous mechanical thrombectomy (PMT) to treat patients with acute iliofemoral deep vein thrombosis (DVT). This observational, prospective cohort study compares the ClotTriever System with aspiration thrombectomy (including rheolytic thrombectomy) to see if the ClotTriever System improves thrombus removal, reduces post-thrombotic syndrome (PTS), and enhances the long-term results of endovascular treatment. Participants receive treatment using one of two types of mechanical thrombectomy devices. The ClotTriever System procedure is done through the ipsilateral popliteal vein or femoral vein, with access established under imaging guidance, followed by thrombectomy and evaluation of clot removal by venography. The aspiration thrombectomy group uses mechanical aspiration devices via similar vein access points, also assessing clot removal with venography. During the study, patients are monitored for PTS incidence at 24 months, with additional evaluations at 6, 12, and 24 months including PTS severity, clinical classification, vein patency, DVT recurrence, re-intervention rates, and quality of life. The study involves long-term follow-up to assess outcomes and safety. Participants sign informed consent and undergo endovascular treatment within 14 days of symptom onset.
CONDITIONS
Brief Title
Comparison Of Different Mechanical Thrombectomy Devices in Endovascular Treatment of Acute Iliofemoral Venous Thrombosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 85 years
- Diagnosed with acute iliofemoral venous thrombosis involving at least the iliac vein and common femoral vein
- Time from symptom onset to endovascular treatment is 14 days or less
- Undergoing endovascular treatment with percutaneous mechanical thrombectomy
- Signed informed consent form
You will not qualify if you...
- Presence of post-thrombotic syndrome in the treated limb or history of symptomatic deep vein thrombosis in the same limb within the past 2 years
- Symptomatic acute deep vein thrombosis involving the iliac vein and/or common femoral vein in the opposite limb
- Known allergy to heparin, low molecular weight heparin, or contrast agents
- Severe pulmonary embolism with unstable blood flow or low oxygen levels
- Unable to tolerate endovascular treatment due to severe illness or breathing problems
- Severe kidney problems with creatinine clearance below 30 ml/min
- Active bleeding, severe liver problems, or bleeding disorders
- Severe anemia with hemoglobin below 8.0 mg/dL or low platelet count below 80,000/mL
- History of brain hemorrhage, brain vascular malformations, or brain aneurysm
- Pregnant women
- Other serious diseases with expected life expectancy less than 24 months
- Participation in any drug or medical device trial that may interfere within the past month
- Unwillingness to participate in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment procedure
Participants undergo percutaneous mechanical thrombectomy using either the ClotTriever System or aspiration/rheolytic thrombectomy devices to remove acute iliofemoral venous thrombosis.
1 treatment visit (in-person)
Duration - Up to 24 months
Participants are monitored for the incidence of post-thrombotic syndrome, vein patency, recurrence of deep vein thrombosis, and quality of life over time.
Visits at 6, 12, and 24 months (in-person)
Trial Site Locations
Total: 1 location
1
Renji hospital
Shanghai, China
Actively Recruiting
Research Team
Q
Qihong Ni
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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