Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
NCT06422845 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328
Last updated 2025-01-09
Summary
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.
Conditions
- Arteriovenous Fistula Stenosis
Interventions
- DEVICE
-
Dissolve AV Peripheral Scoring Drug-coated Balloon
Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon
Sponsors & Collaborators
-
DK Medical Technology (Suzhou) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yuzhu Wang, MD · Beijing Haidian Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-30
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- China
Study Locations
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