Paclitaxel-Coated Balloon for the Treatment of AVF

NCT05088083 | Unknown

• 1 other identifier: V1.0
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arteriovenous Fistula

Keywords

DCB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Device Success

  Time of procedure

• Clinical Success

  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.

• Procedural Success

  2 weeks

Study Arms (1)

DCB Treatment Group

EXPERIMENTAL

Subjects treated with DCB

Device: Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

Interventions

Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon DEVICE

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

Also known as: Zylox

DCB Treatment Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Zylox Medical Device Co., Ltd.: lead

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lan Zhang

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Liang, Bachelor

CONTACT

13819565660; jie.liang@zyloxmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 21, 2021
• Study Start: December 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share