Deep venous thrombosis of lower extremity requiring percutaneous intervention.
Conditions
Interventions
Eperimental group:Interventional surgery
Sponsors
Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Version number and date for subjects between the ages of 18 and 85; 2.Patients diagnosed with deep vein thrombosis (DVT) within 30 days of onset by color Doppler ultrasound (CDUS) or CT venography (CTV) or deep venography of the lower extremity; 3.Target lesions involved the inferior vena cava, common iliac vein, external iliac vein, common femoral vein, superficial femoral vein, or popliteal vein; 4.Subjects who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to follow up
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with chronic stage deep vein thrombosis (confirmed by color Doppler ultrasound (CDUS) or CT venography (CTV) or lower extremity deep venography imaging more than 30 days) 2.Patients with thrombosis involving deep veins of the lower extremities on both sides requiring thrombi clearance 3. Patients with known coagulation dysfunction or bleeding tendency (platelets 3) 4.Severe liver and kidney diseases: renal insufficiency, impaired renal function (estimated glomerular filtration rate (GFR) 3 times the upper limit of normal have a history of heart failure, stroke, and/or myocardial infarction within 5.1 months, or are scheduled to undergo coronary revascularization, carotid revascularization, or other major cardiovascular and cerebrovascular surgery 6.Target lesions involve venous vessels 14 and/or presence of skin ulcers) who had undergone percutaneous mechanical thrombus removal within 16.Patients who had undergone percutaneous mechanical thrombus removal within 1 month 17.Patients with anticoagulant contraindications (e.g., heparin-induced thrombocytopenia (HIT)). 18. Patients with thrombolytic contrainminations (? hypersensitivity to thrombolytic drugs;Patients with high risk of bleeding and recent (within 2 to 4 weeks) active bleeding, including severe intracranial, gastrointestinal, and urinary tract bleeding;? Recent major surgery, biopsy, version number and date: V1.2/2022-10-10V1.2 page 3 / A total of 5 pages of cardiopulmonary resuscitation, puncture without compression;? Recent severe trauma;? severe and difficult to control hypertension [blood pressure greater than 160/110mmHg (1mmHg=0.133kPa)];? Bacterial endocarditis;? Patients with aneurysm, aortic dissection, arteriovenous malformation.) 19. Patients with a history of allergy to Nitinol 20. Patients who participated in clinical trials of other drugs or devices that were not completed 21.Patients whom the investigators deemed inappropriate to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse events (MAE) at 30 days after surgery;Recurrence rate of target lesion 1, 3 and 6 months after operation;Incidence of postthrombotic syndrome 1, 3 and 6 months after surgery;Thrombus clearance;Instrument success rate;Operation success rate;Intravenous clinical severity (VCSS) scores 1, 3, and 6 months after surgery;Chronic Venous Insufficiency Questionnaire (CIVIQ-20) scores 1, 3 and 6 months after surgery;Incidence of adverse events 1, 3 and 6 months after surgery;Incidence of serious adverse events 1, 3 and 6 months after surgery; | — |
Countries
China
Contacts
Public ContactXinwu Lu
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Outcome results
None listed