Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients
1 other identifier
interventional
256
0 countries
N/A
Brief Summary
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedStudy Start
First participant enrolled
September 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedSeptember 8, 2023
August 1, 2023
2 years
August 24, 2023
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
6-month target lesion primary patency rate
Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.
6months
Secondary Outcomes (3)
Device success rate
The day of operation.
Surgical success rate
7Days
Clinical success rate
1year
Study Arms (2)
Rapamycin coated balloon dilation catheter for arteriovenous fistula
EXPERIMENTALExperimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion
Paclitaxel release high-pressure shunt balloon dilation catheter
SHAM COMPARATORStrict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group
Interventions
Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.
Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.
Eligibility Criteria
You may qualify if:
- AVF has been established, with mature development and at least one successful completion of hemodialysis；
- AVF has significant hemodynamic abnormalities；
You may not qualify if:
- The target lesion has undergone intervention treatment within 30 days；
- An intravascular stent has been placed at any location along the vascular pathway；
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2023
First Posted
September 8, 2023
Study Start
September 15, 2023
Primary Completion
September 15, 2025
Study Completion
December 15, 2025
Last Updated
September 8, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share