Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

Shanghai Bomaian Medical Technology

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease

Treatments: Procedure: Rapamycin drug balloon angioplasty; Procedure: Paclitaxel drug balloon angioplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT06029569

BMA-AVF-DCB

Details and patient eligibility

About

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

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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；

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

Rapamycin coated balloon dilation catheter for arteriovenous fistula

Experimental group

Description:

Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion

Treatment:

Procedure: Rapamycin drug balloon angioplasty

Procedure: Paclitaxel drug balloon angioplasty

Paclitaxel release high-pressure shunt balloon dilation catheter

Sham Comparator group

Description:

Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group

Treatment:

Procedure: Rapamycin drug balloon angioplasty

Procedure: Paclitaxel drug balloon angioplasty