NCT05498740

Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia

Post-marketing Study in Femoral Popliteal Artery of Drug Coated Ballon Used for Treatment of Lower Limb Ischemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Zhejiang Zylox Medical Device Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).

Conditions

• Peripheral Arterial Disease (PAD)

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: 2022-05-04
• Primary completion: 2022-12-01
• Completion: 2024-12-01
• First posted: 2022-08-12
• Last updated: 2022-08-12

Locations

24 sites across 1 country: China