chronic kidney disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18-80 years old; 2.Venous stenosis of autologous arteriovenous fistula, with stenosis >=50%, and at least one clinical, physiological, or hemodynamic abnormality attributable to stenosis as defined in the KDOQI guidelines; 3.A single stenotic lesion, which can be a primary stenosis or a recurrent stenosis after PTA treatment; 4.Voluntarily participate in this study and sign the informed consent form.If the subject is unable to read and sign the informed consent due to incapacity or other reasons, the guardian shall act as the agent for the informed process and sign the informed consent. If the subject does not have the ability to read the informed consent (illiterate subject), a witness must witness the informed process and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. stenosis can not be fully expanded; 2.PTA thrombosis in short time; 3. Patients with concurrent stent implantation in DCB; 4. Life expectancy of subjects <12 months; 5.Vulnerable groups in addition to illiteracy, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Internal diameter at target lesion before surgeon ;Intimal thickness at target lesion before surgeon ;6-month primary patency rate of target lesions ;Internal diameter at target lesion after pre-dilatation;Intimal thickness at target lesion after pre-dilatation;Internal diameter at target lesion after drug-coated balloon dilatation;Intimal thickness at target lesion after drug-coated balloon dilatation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of target lesion ; | — |
Countries
China
Contacts
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine