NCT05415995

A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Zhejiang Zylox Medical Device Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

Detailed description

This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Drug eluting Balloon	Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2022-06-13
• Last updated: 2022-06-13

Locations

20 sites across 1 country: China