Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

NCT ID: NCT06029569

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2025-12-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rapamycin coated balloon dilation catheter for arteriovenous fistula

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

Group Type EXPERIMENTAL

Rapamycin drug balloon angioplasty

Intervention Type PROCEDURE

Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.

Paclitaxel drug balloon angioplasty

Intervention Type PROCEDURE

Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.

Paclitaxel release high-pressure shunt balloon dilation catheter

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

Group Type SHAM_COMPARATOR

Rapamycin drug balloon angioplasty

Intervention Type PROCEDURE

Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.

Paclitaxel drug balloon angioplasty

Intervention Type PROCEDURE

Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.

Interventions

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Rapamycin drug balloon angioplasty

Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.

Intervention Type PROCEDURE

Paclitaxel drug balloon angioplasty

Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Bomaian Medical Technology Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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qizhuang Jin

Role: CONTACT

010-83572211

Other Identifiers

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BMA-AVF-DCB

Identifier Type: -

Identifier Source: org_study_id

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