Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

Sponsor

Shanghai Bomaian Medical Technology Co., Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06029569

Collaborator

(none)

256

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Procedure: Rapamycin drug balloon angioplasty Procedure: Paclitaxel drug balloon angioplasty	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Sep 15, 2025

Anticipated Study Completion Date :

Dec 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rapamycin coated balloon dilation catheter for arteriovenous fistula Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion	Procedure: Rapamycin drug balloon angioplasty Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula. Procedure: Paclitaxel drug balloon angioplasty Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.
Sham Comparator: Paclitaxel release high-pressure shunt balloon dilation catheter Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group	Procedure: Rapamycin drug balloon angioplasty Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula. Procedure: Paclitaxel drug balloon angioplasty Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.

Arm

Intervention/Treatment

Experimental: Rapamycin coated balloon dilation catheter for arteriovenous fistula

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

Procedure: Rapamycin drug balloon angioplasty

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

Procedure: Paclitaxel drug balloon angioplasty

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

Sham Comparator: Paclitaxel release high-pressure shunt balloon dilation catheter

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

Procedure: Rapamycin drug balloon angioplasty

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

Procedure: Paclitaxel drug balloon angioplasty

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

AVF has been established, with mature development and at least one successful completion of hemodialysis；
AVF has significant hemodynamic abnormalities；

exclusion criteria

The target lesion has undergone intervention treatment within 30 days；
An intravascular stent has been placed at any location along the vascular pathway；

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Bomaian Medical Technology Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Bomaian Medical Technology Co., Ltd

ClinicalTrials.gov Identifier:

NCT06029569

Other Study ID Numbers:

BMA-AVF-DCB

First Posted:

Sep 8, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Sirolimus

Paclitaxel

Study Results

No Results Posted as of Sep 8, 2023