NCT03366727

AcoArt III / Arterio-venous Fistula in China

Drug-eluting Balloon for Arteriovenous Fistula in China

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Acotec Scientific Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Arteriovenous Fistula Stenosis

Interventions

Type	Name	Description
DEVICE	drug-coated balloon catheter （Orchid, Acotec）	After predilation, using drug-coated balloon catheter to cover the whole treated segment
DEVICE	plain balloon catheter (Admiral, medtronic)	After predilation, using plain balloon catheter to cover the whole treated segment

Timeline

• Start date: 2018-05-01
• Primary completion: 2021-06-01
• Completion: 2022-07-07
• First posted: 2017-12-08
• Last updated: 2022-07-27

Locations

13 sites across 1 country: China