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The correlation between ultrasonic morphological characteristics and morphological changes after predilation of vascular stenosis and the therapeutic effect of drug-coated balloon on arteriovenous fistula stenosis

The correlation between ultrasonic morphological characteristics and morphological changes after predilation of vascular stenosis and the therapeutic effect of drug-coated balloon on arteriovenous fistula stenosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097414
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease

Interventions

Control group:none
Endpoint group:None

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime 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

MeasureTime frame
Length of target lesion ;

Countries

China

Contacts

Public ContactLu Mingxi

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

lumingxi666@163.com+86 139 5818 1994

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026