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Completed
NCT07857850
A Prospective, Multicenter, Single-Arm Trial of Peripheral Vein Thrombectomy Stent System in Deep Venous Thrombosis
Conditions: DVT - Deep Vein Thrombosis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 132
Sponsor: Shanghai TENDFO Medical Technology Co., Ltd.
Location: Xiamen Cardiovascular Hospital Xiamen University Xiamen Fujian
Summary
To evaluate the safety and efficacy of peripheral vein thrombectomy stent system produced by Shanghai Tendfu Medical Technology Co., Ltd. in the treatment of acute or subacute deep venous thrombosis.
Eligibility Criteria
Inclusion Criteria:
1. Subjects aged between 18 and 80 years.
2. Patients diagnosed with deep venous thrombosis (DVT) within 30 days of onset via color Doppler ultrasound (CDUS) or CT venography (CTV) imaging.
3. Target lesions involving the inferior vena cava, common iliac vein, external iliac vein, common femoral vein, superficial femoral vein, or popliteal vein.
4. Subjects capable of understanding the purpose of the trial, who voluntarily participate and sign an informed consent form, and are willing to undergo follow-up evaluations.
Exclusion Criteria:
1. Patients diagnosed with chronic-phase deep venous thrombosis (DVT) (symptom onset \>30 days).
2. Patients with bilateral lower extremity DVT requiring thrombus removal in both limbs.
3. Patients with known bleeding disorders or bleeding tendencies (platelet count \3).
4. Severe hepatic or renal dysfunction Renal insufficiency (estimated glomerular filtration rate \[GFR\] \3 × upper limit of normal (ULN).
5. History of heart failure, stroke, and/or myocardial infarction within 1 month, or planned coronary/carotid revascularization or major cardiovascular/cerebrovascular surgery.
6. Target lesions involving veins with a diameter \14 points and/or skin ulcers).
16. Patients who underwent percutaneous mechanical thrombectomy within 1 month.
17. Contraindications to anticoagulation (e.g., heparin-induced thrombocytopenia \[HIT\]).
18. Contraindications to thrombolysis:
Allergy to thrombolytic agents; High bleeding risk or active bleeding within 2 - 4 weeks (e.g., intracranial, gastrointestinal, or urinary tract hemorrhage); Recent major surgery, biopsy, CPR, or non-compressible puncture; Severe trauma within 2 - 4 weeks; Uncontrolled hypertension (\>160/110 mmHg); Bacterial endocarditis; Aortic dissection, aneurysm, or arteriovenous malformation.
19. History of nickel-titanium (Nitinol) alloy allergy.
20. Participation in other ongoing drug/device clinical trials.
21. Patients deemed ineligible by the investigator.
Source: ClinicalTrials.gov (NCT07857850). StuddyBuddy aggregates publicly available trial information.