Iliofemoral venous obstruction
Conditions
Interventions
Sponsors
Yuhuangding Hospital in Yantai
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 or older, and life expectancy assessed by the researchers to be more than 1 year; 2. The subject's target lesions (single or multiple lesions of common iliac vein, external iliac vein, and common femoral vein) are non-tumorinduced obstruction, and unilateral or bilateral target lesions can be treated with study stent, and the lumen diameter stenosis >=50% or occlusion (can be evaluated by CT vein imaging or DSA vein angiography); 3. Acute lower extremity venous thrombosis, and thrombus can be effectively cleared, or chronic lower extremity venous disease diagnosis CEAP "C" >=3; 4. Subjects can understand the purpose of the study and should be able to participate in.
Exclusion criteria
Exclusion criteria: (1) Patients with severe pulmonary embolism; (2) Patients with venous obstruction extending to inferior vena cava or distal to lesions involving deep femoral vein openings; (3) Patients whose target vessels have undergone open surgery such as bypass surgery or stent placement requiring reintervention; (4) Patients with major organ failure or other serious diseases (including malignant tumors, grade 3 or 4 of cardiac function, and a history of severe neurological or mental illness;Myocardial infarction, ischemic stroke and hemorrhagic stroke within 3 months before enrollment;Severe infection;Acute and chronic renal failure); (5) Patients with known allergic reactions to contrast agents, nickel or titanium (Nitinol), aspirin, heparin, clopidogrel, cilostazol and other anticoagulants; (6) The patient has participated in, is participating in, or plans to participate in clinical trials of any other device or drug within the last 1 month; (7) Women of childbearing age who have a positive pregnancy test during screening, or who are pregnant, breast-feeding or planning to have a family planning within one year; (8) Patients who have no suitable approach for target lesions, or plan to receive surgical or interventional treatment for target lesions within one month before and after enrollment (except for perioperative thrombolysis and/or thrombotomy for target lesions, placement of vena cava filter to reduce the risk of pulmonary embolism, etc.); (9) Those who are not considered suitable for clinical trials by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point was CT angiography or DSA angiography to evaluate the patency of the target lesion in 6 months.; | — |
Countries
China
Contacts
Public ContactHaijie Che
Yuhuangding Hospital
Outcome results
None listed