Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Rapamycin drug balloon angioplasty; Procedure: Paclitaxel drug balloon angioplasty

• Registration Number: NCT06029569
• Lead Sponsor: Shanghai Bomaian Medical Technology Co., Ltd

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

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08
• Study Start: 2023-09-15
• Primary Completion: 2025-09-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 256

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；

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapamycin coated balloon dilation catheter for arteriovenous fistula	Rapamycin drug balloon angioplasty	Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion
Rapamycin coated balloon dilation catheter for arteriovenous fistula	Paclitaxel drug balloon angioplasty	Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion
Paclitaxel release high-pressure shunt balloon dilation catheter	Rapamycin drug balloon angioplasty	Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group
Paclitaxel release high-pressure shunt balloon dilation catheter	Paclitaxel drug balloon angioplasty	Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group

Primary Outcome Measures

Name	Time	Method
6-month target lesion primary patency rate	6months	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.

Secondary Outcome Measures

Name	Time	Method
Surgical success rate	7Days	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.
Device success rate	The day of operation.	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.
Clinical success rate	1year	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.