Status:
UNKNOWN
Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
Lead Sponsor:
Shanghai Bomaian Medical Technology Co., Ltd
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
Detailed Description
To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in the treatment ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- AVF has been established, with mature development and at least one successful completion of hemodialysis；
- AVF has significant hemodynamic abnormalities；
- exclusion criteria
- The target lesion has undergone intervention treatment within 30 days；
- An intravascular stent has been placed at any location along the vascular pathway；
Exclusion
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06029569
Start Date
September 15 2023
End Date
December 15 2025
Last Update
September 8 2023
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