Venous anastomosis stenosis
Conditions
Interventions
Control group:Patients received covered stent implantation
AI Experimental groupAI· :implantation of paclitaxel-eluting stents
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Hemodialysis patients aged >=18 and =50% measured by reference scale under DSA, accompanied by at least one of the following clinical manifestations: elevated dialysis venous pressure, decreased native access blood flow (AVG 30% after balloon angioplasty or in-stent restenosis occurring within 3 months; 7.Patients voluntarily signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Lower extremity arteriovenous graft (AVG); 2.Target lesion with previous stent implantation, or ipsilateral central vein stenosis/occlusion affecting access function; 3.Severe lesions that cannot be fully dilated by balloon; 4.Patients undergoing interventional recanalization for acute AVG thrombosis; 5.Vascular rupture and bleeding during dilation; 6.Poorly controlled blood pressure: baseline blood pressure below 90/60 mmHg, or hypotension occurring in more than half of dialysis sessions; 7.Patients who received major surgical treatment within 30 days prior to enrollment; 8.Patients with known allergy or intolerance to contrast agents or paclitaxel; 9.Patients with vascular access infection or systemic active infection; 10.Patients receiving glucocorticoids (prednisone <=10 mg/d) or immunosuppressive therapy; 11.Patients with a life expectancy of less than 1 year; 12.Patients scheduled for renal transplantation or conversion to peritoneal dialysis; 13.Patients deemed unsuitable for participation by the investigators; 14.Patients participating in other ongoing drug or device clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month primary patency rate of target lesion; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month target lesion primary patency rate;6-month access primary patency rate;Incidence of stent edge stenosis at 6 months;12-month access primary patency rate;Incidence of stent edge stenosis at 12 months; | — |
Countries
China
Contacts
Public ContactYaxue Shi
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed