Iliofemoral venous obstruction
Conditions
Interventions
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-80 years old, and the researchers assessed their life expectancy for more than 1 year; (2) acute lower extremity venous thrombosis, and thrombus can be effectively cleared, or chronic lower extremity venous disease diagnosis CEAP "C" >=3 or VCSS pain score >=2; (3) Subjects can understand the purpose of the study and should be able to participate in clinical trials and sign informed consent in conjunction with clinical follow-up.
Exclusion criteria
Exclusion criteria: (1) Patients with high-risk pulmonary embolism within 6 months prior to enrollment; (2) The target vessel has undergone open surgery such as bypass surgery or patients who have been implanted with stents for interventional therapy; (3) Patients with important organ failure or other serious diseases (including malignant tumors, grade 3 or 4 of cardiac function, history of severe neurological or psychiatric disorders; myocardial infarction, ischemic stroke within the first 3 months of enrollment, Hemorrhagic stroke; severe infection; acute and chronic renal failure); (4) Suffering from severe coagulopathy; (5) Patients known to be allergic to nickel or titanium (nickel-titanium alloy), contrast agents, anticoagulant antiplatelet drugs; (6) Clinical trials in which patients have participated in, participated in, or will plan to participate in any other device or drug within the last month; (7) Females of childbearing age who have a positive pregnancy test during the screening period, or who are pregnant, lactating or expecting a birth plan within one year; (8) There is no suitable approach for target lesions, or surgical or interventional surgery is planned to receive target lesions within one month before and after enrollment (perioperative thrombolysis and/or thrombectomy for target lesions, reduction of vena cava filter placement) Patients with a risk of pulmonary embolism, etc.); (9) The investigator believes that the subject has other conditions that are not suitable for clinical trials, such as follow-up compliance, and cannot be returned on time for regular follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint was the primary patency rate at 12 months for target lesions assessed by DSA (acceptable for CTV).; | — |
Countries
China
Contacts
Public ContactXiaoming Zhang
Peking University People's Hospital
Outcome results
None listed