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NCT07622199
PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
Conditions: Deep Vein Thrombosis
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: RenJi Hospital
Location: Renji hospital Shanghai
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years and ≤ 85 years;
2. Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and PFV (confirmed by preoperative ultrasound, CT venography, or intraoperative venography);
3. Time from symptom onset to endovascular treatment ≤ 14 days;
4. Patient receives endovascular treatment with PMT;
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 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 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.
Source: ClinicalTrials.gov (NCT07622199). StuddyBuddy aggregates publicly available trial information.
