Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06029569
• Other study ID #: BMA-AVF-DCB
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: August 2023
• Source: Shanghai Bomaian Medical Technology Co., Ltd
• Contact: qizhuang Jin
• Phone: 010-83572211
• Email: jinqizhuang[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: December 15, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. AVF has been established, with mature development and at least one successful completion of hemodialysis;

2. AVF has significant hemodynamic abnormalities;

exclusion criteria

1. The target lesion has undergone intervention treatment within 30 days;

2. An intravascular stent has been placed at any location along the vascular pathway;

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Rapamycin drug balloon angioplasty
Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.
• Paclitaxel drug balloon angioplasty
Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Bomaian Medical Technology Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Device success rate	The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure.	The day of operation.
Secondary	Surgical success rate	The residual stenosis of the target lesion is = 30%, and there are no adverse events related to the target dialysis pathway related to medical devices within 7 days after surgery/before discharge.	7Days
Secondary	Clinical success rate	After the surgery, at least one puncture dialysis that meets the requirements of the dialysis prescription has been completed and no target pathway dysfunction has occurred before.	1year