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โ† Trials
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PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis

RecruitingNAAges 18 Years - 85 YearsAllRenJi Hospital
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In plain words

What the trial is, and whether it could suit you

Patients with iliofemoral vein thrombosis are prone to developing post-thrombotic syndrome (PTS). The profunda femoris vein (PFV) is an important inflow of the iliofemoral vein. Profunda femoris vein thrombosis clearance (PFV-TC) may improve the patency of iliofemoral vein and reduce the occurrence of PTS.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 18 years and โ‰ค 85 years; 2. Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and the proximal segment (orifice) of PFV (confirmed by preoperative ultrasound, CT venography, or pre-procedural venography); 3. Time from symptom onset to endovascular treatment โ‰ค 14 days; 4. Patient receives endovascular treatment with rapid endovascular thrombus removal device; 5. Patient provides written informed consent. Exclusion Criteria: 1. Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb; 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 media, or other relevant agents; 4. Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension; 5. Intolerance to endovascular intervention due to concurrent acute systemic illness, severe dyspnea, or other contraindications; 6. Concomitant severe renal insufficiency with creatinine clearance \< 30 ml/min; 7. Presence of active bleeding, severe hepatic insufficiency, bleeding diathesis, or other coagulation disorders; 8. Concomitant severe anemia (hemoglobin \< 8.0 mg/dL) or thrombocytopenia (platelet count \< 80,000/mL); 9. History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm; 10. Pregnancy; 11. Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency) with an estimated life expectancy \< 24 months; 12. Participation in another clinical trial of a drug or medical device within the past 1 month that may interfere with the present study; 13. Unwillingness to participate in this trial.
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What it tests

  • Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC)
  • Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)
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Where

1 site
Renji hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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