Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

This study is a prospective, single-center, observational study. In this study, we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease. It is expected to include about 400 patients diagnosed with lower extremity arterial occlusive disease in our center from July 2024 to July 2026. All enrolled patients will be followed for three years. All patients diagnosed with arteriosclerosis obliterans (ASO) and all treatment techniques were included in this study. The primary outcomes include the Efficacy and Safety End Points of each techniques.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older, gender is not limited.

• Patients diagnosed with arteriosclerosis obliterans.

• Rutherford stages 2-6.

• When there are multiple stenosis lesions, the treatment of the most severe lesion is included.

• Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included.

Locations
Other Locations
China
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Haoliang Wu
wu18738957806@126.com
18738957806
Backup
Zilun Li
lizilun@mail.sysu.edu.cn
13760871576
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2029-07
Participants
Target number of participants: 400
Treatments
Bypass group
open bypass group
BMS group
BMS (bare metal stent) group
POBA group
POBA (plain old balloon angioplasty) group
DCB group
drug-coated balloon group
DA group
DA (directional atherectomy) group
HR group
HR (hybrid repair) group
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov