NCT05158283

Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.

Detailed description

Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the chocolate balloon group and plain balloon dilatation group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments.

Conditions

• Atherosclerosis
• Ischemia

Interventions

Type	Name	Description
DEVICE	chocolate balloon	chocolate balloon dilatation
DEVICE	plain balloon	plain balloon dilatation

Timeline

• Start date: 2021-08-30
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2021-12-15
• Last updated: 2022-10-12

Locations

1 site across 1 country: China