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NCT06029569

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
Shanghai Bomaian Medical Technology Co., Ltd·ClinicalTrials.gov·procedureNot yet recruiting
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Study focus
Disease/Condition
Peripheral Arterial Disease
Drug/Device/Intervention
Rapamycin drug balloon angioplasty
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Shanghai Bomaian Medical Technology Co., Ltd
Timeline & enrollment
Phase
N/A
Start date
Sep 15, 2023
End date
Dec 15, 2025
Enrollment
256 participants
Primary outcome

6-month target lesion primary patency rate

Summary

Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the
 treatment of dialysis pathway stenosis or blockage lesions.

ICD-10 classifications
Peripheral vascular disease, unspecifiedOther peripheral vascular diseasesOther specified peripheral vascular diseasesPeripheral angiopathy in diseases classified elsewhereOther congenital malformations of peripheral vascular system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06029569
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06029569 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai Bomaian Medical Technology Co., Ltd and is currently Not yet recruiting. The study focuses on Peripheral Arterial Disease. Target enrollment is 256 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.