NCT05158257

Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon 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 endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.

Detailed description

Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the endovascular debulking combined drug-coated balloon group and balloon dilatation combined with stent angioplasty group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.

Conditions

• Atherosclerosis
• Ischemia

Interventions

Type	Name	Description
DEVICE	balloon and Stent	balloon dilatation combined stent angioplasty
DEVICE	endovascular debulking and DCB	endovascular debulking combined drug-coated balloon

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-10-10
• Completion: 2023-12-01
• First posted: 2021-12-15
• Last updated: 2022-10-12

Locations

1 site across 1 country: China