Central venous stenosis or occlusion
Conditions
Interventions
Experimental group:Drug Coated Vascular Endoprothesis
Control group:PTA Balloon Dilatation Catheter
Sponsors
The First Affiliated Hospital Of Chongqing Medical University/West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients must meet all the following criteria: (1) Age 18-80 years old (inclusive), both sexes; (2) Target lesion located in the central vein (including superior vena cava, innominate vein, subclavian vein, inferior vena cava, iliac vein); (3) Target lesion stenosis >50%, and clinical symptoms consistent with stenosis, such as: elevated dialysis venous pressure, tumor-like expansion of internal fistula with positive arm-raising test, limb swelling, etc.; (4) Target lesion is primary or restenosis lesion, reference vessel diameter is between 4.0-17.0mm, total length is =120mm (a single stent can be completely covered); (5) Voluntary participation in this study, understanding all the risks and benefits described in the informed consent document, and signing the written informed consent.
Exclusion criteria
Exclusion criteria: Patients were excluded if they met any of the following criteria: (1) admission to the intensive care unit for any reason, stroke (except TIA), or coronary surgery (including endovascular procedures) within 3 months before enrollment; (2) known allergies to contrast media, heparin, warfarin, lidocaine, antiplatelet agents, PTFE, or nitinol; (3) severe liver dysfunction (ALT > 3 times the upper limit of normal); (4) planned kidney transplantation or planned conversion to peritoneal dialysis within one year; (5) known severe bleeding or coagulation disorders; (6) receiving immunosuppressive therapy, vascular access infection, or systemic active infection; (7) chronic hypotension or heart failure during dialysis; (8) inadequate expansion of the target lesion to allow the delivery system to pass; (9) acute thrombosis of the central vein; (10) The degree of stenosis in other pathways beyond the target lesion is greater than 50% and requires treatment; (11) other conditions that may make the trial difficult or significantly shorten life expectancy (<1 year); (12) pregnant or lactating women, or subjects who planned to become pregnant during the trial; (13) patients participating in other clinical trials of drugs or medical devices; (14) patients who were deemed ineligible for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate of target lesions 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Success rate of operation;Restenosis rate of target lesion 12 months after surgery;Primary patency rate of target lesions at 3 and 6 months after operation;The secondary patency rate of target lesions at 3 months, 6 months and 12 months after surgery;Device-related adverse events and serious adverse events;Other adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactFu Qining/Zhao Jichun
The First Affiliated Hospital Of Chongqing Medical University/West China Hospital of Sichuan University
Outcome results
None listed