Paclitaxel-Coated Balloon for the Treatment of AVF

Zhejiang Zylox Medical Device

Status

Unknown

Conditions

Arteriovenous Fistula

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05088083

V1.0

Details and patient eligibility

About

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.

Enrollment

143 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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