Paclitaxel-Coated Balloon for the Treatment of AVF

Arteriovenous Fistula Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05088083
• Other study ID #: V1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: September 2023

Study information

• Verified date: October 2021
• Source: Zhejiang Zylox Medical Device Co., Ltd.
• Contact: Jie Liang, Bachelor
• Phone: 13819565660
• Email: jie.liang[@]zyloxmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 143
• Est. completion date: September 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Device:
• Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
After predilation, using drug-coated balloon catheter to cover the whole treated segment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Device Success	Successful delivery to the target lesion, deployment, and retrieval at index procedure	Time of procedure
Secondary	Clinical Success	The resumption of dialysis for at least one session after the index procedure	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.
Secondary	Procedural Success	Maintenance of patency (=30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).	2 weeks