NCT05662618

To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease

Prospective, Multicenter, Randomized Controlled Clinical Trial to Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Shanghai Bomaian Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
PROCEDURE	Percutaneous selective arteriography of peripheral arteries	Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
PROCEDURE	Percutaneous selective arteriography of peripheral arteries	Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.

Timeline

• Start date: 2022-12-31
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-12-22
• Last updated: 2022-12-22

Locations

1 site across 1 country: China