AcoArt III / Arterio-venous Fistula in China

Acotec Scientific

Status

Completed

Conditions

Arteriovenous Fistula Stenosis

Treatments

Device: plain balloon catheter (Admiral, medtronic)

Device: drug-coated balloon catheter （Orchid, Acotec）

Study type

Interventional

Funder types

Industry

Identifiers

NCT03366727

Acotec-05

Details and patient eligibility

About

This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.

Full description

For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia and drug-coated balloons,therefore, it represents an attractive option for AVF stenoses.

Enrollment

244 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