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Transcutaneous drug-coated balloon based on ultrasound support for the treatment of stenosis caused by calcification of arteriovenous fistula

Transcutaneous drug-coated balloon based on ultrasound support for the treatment of stenosis caused by calcification of arteriovenous fistula

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034040
Enrollment
Unknown
Registered
2020-06-21
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Arteriovenous fistula

Interventions

single arm:Transcutaneous drug-coated balloon based on ultrasound support

Sponsors

The Eighth Affiliated Hospital, Sun Yat-Sen University (Shenzhen Futian)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who sign informed consent to participate in the study and abide by the study procedure; 2. Patients with chronic renal failure who have maintained hemodialysis for more than one year; 3. The stenosis of arteriovenous fistula was diagnosed by color Doppler ultrasound; 4. According to the standard clinical application guidelines of the research unit, the patients who have no evidence of cardiovascular and cerebrovascular events in physical examination, imaging and laboratory examination 4 weeks before enrollment; 5. Patients who are negative in pregnancy test and willing to use contraception during treatment.

Exclusion criteria

Exclusion criteria: 1. Patients with arteriovenous fistula infection; 2. Patients with arteriovenous fistula occlusion; 3. Patients with central vein stenosis or occlusion; 4. Patients with active infection; 5. Patients who have serious complications and are unable to operate; 6. Patients who do not have legal capacity or whose legal capacity is limited; 7. Patients with severe heart, liver and lung dysfunction; 8. Any other circumstances that the investigator considers unsuitable for the trial; 9. The researcher's judgment compliance is not good, and the scheme cannot be strictly implemented.

Design outcomes

Primary

MeasureTime frame
PSV;EDV;RI;PI;AT;MDV;TAPVC;SA;

Countries

China

Contacts

Public ContactHuang Hui

The Eighth Affiliated Hospital, Sun Yat-Sen University (Shenzhen Futian)

huanghui765@hotmail.com+86 13923730765

Outcome results

None listed

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