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Paclitaxel-Coated Balloon for the Treatment of AVF (AVF)

Primary Purpose

Arteriovenous Fistula

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

About this trial

This is an interventional treatment trial for Arteriovenous Fistula focused on measuring DCB

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age during 18-85 years old
Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
Venous stenosis of the AV fistula
target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
the length of target lesion ≤100mm
Patient able to give informed consent
residual stenosis ≤30% after predilation

Exclusion Criteria:

Women who are breastfeeding, pregnant or are intending to become pregnant
AVF located at lower limbs
Two or more than two stenosis at the target vessel.
Obstruction of central venous return
ISR
AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
Vascular access has surgery in 30 days or intending to undergo a surgery
Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
Patients undergoing immunotherapy or suspected / confirmed vasculitis
Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
Vascular access infection or systemic active infection
Patients's life expectancy is less than 12 months
Renal transplantation has been planned or converted to peritoneal dialysis
Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
Involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DCB Treatment Group

Arm Description

Subjects treated with DCB

Outcomes

Primary Outcome Measures

primary patency of target lesion in 6 months

Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention; 2) PSVR< 2.4

Secondary Outcome Measures

Device Success

Successful delivery to the target lesion, deployment, and retrieval at index procedure

Clinical Success

The resumption of dialysis for at least one session after the index procedure

Procedural Success

Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).

Full Information

NCT ID

NCT05088083

First Posted

September 20, 2021

Last Updated

October 7, 2021

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05088083

Brief Title

Paclitaxel-Coated Balloon for the Treatment of AVF

Acronym

AVF

Official Title

Single-arm Study of Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 2021 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arteriovenous Fistula

Keywords

DCB

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

143 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DCB Treatment Group

Arm Type

Experimental

Arm Description

Subjects treated with DCB

Intervention Type

Device

Intervention Name(s)

Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

Other Intervention Name(s)

Zylox

Intervention Description

After predilation, using drug-coated balloon catheter to cover the whole treated segment

Primary Outcome Measure Information:

Title

primary patency of target lesion in 6 months

Description

Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention; 2) PSVR< 2.4

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Device Success

Description

Successful delivery to the target lesion, deployment, and retrieval at index procedure

Time Frame

Time of procedure

Title

Clinical Success

Description

The resumption of dialysis for at least one session after the index procedure

Time Frame

From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.

Title

Procedural Success

Description

Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age during 18-85 years old Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions Venous stenosis of the AV fistula target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow the length of target lesion ≤100mm Patient able to give informed consent residual stenosis ≤30% after predilation Exclusion Criteria: Women who are breastfeeding, pregnant or are intending to become pregnant AVF located at lower limbs Two or more than two stenosis at the target vessel. Obstruction of central venous return ISR AVF with acute thrombosis requiring lysis or thrombectomy in 30 days Vascular access has surgery in 30 days or intending to undergo a surgery Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. Patients undergoing immunotherapy or suspected / confirmed vasculitis Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura Vascular access infection or systemic active infection Patients's life expectancy is less than 12 months Renal transplantation has been planned or converted to peritoneal dialysis Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program Involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Liang, Bachelor

Phone

13819565660

jie.liang@zyloxmedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lan Zhang

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Paclitaxel-Coated Balloon for the Treatment of AVF

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