Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans
NCT Number: NCT06485622
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Arteriosclerosis Obliterans
Interventions: PROCEDURE: open bypass group|PROCEDURE: bare metal stent group|PROCEDURE: plain old balloon angioplasty group|PROCEDURE: drug-coated balloon group|PROCEDURE: directional atherectomy group|PROCEDURE: hybrid repair group
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2029-07
Locations: The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510030, China

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.

Primary Outcome Measures: Limb salvage rate, Freedom from above ankle amputation in target limb., 1 month; 6 months; 12 months; 24 months; 36 months|Primary patency rate, Primary patency of target lesion is assessed by the vascular ultrasound., 1 month; 6 months; 12 months; 24 months; 36 months|Major adverse limb event (MALE) rate, Major adverse limb events include anyone of the following: Amputation in target limb and major re-intervention on target limb., 1 month; 6 months; 12 months; 24 months; 36 months|All cause mortality rate, Death due to any cause., 1 month; 6 months; 12 months; 24 months; 36 months
Secondary Outcome Measures: Restenosis of the target lesion, A peak systolic velocity ratio of over 2.4 measured using duplex ultrasound, \>50% diameter stenosis or occlusion by follow-up angiography., 1 month; 6 months; 12 months; 24 months; 36 months|Major adverse cardiovascular events (MACE), Major adverse cardiovascular events include anyone of the following: Major amputations, myocardial infarction, ischemic stroke, arterial puncture problems requiring intervention, and acute kidney failure associated with endovascular therapy., 1 month; 6 months; 12 months; 24 months; 36 months|Quality-adjusted life-years (QALYs), Time is measured in years and the VascuQol (Vascular Quality-of-Life, scored on a scale from 1 to 7 by using the VascuQol-25 questionnaire) on an index scale ranging from 1 (worst possible) to 7(best possible). The total number of QALYs was calculated by multiplying the HRQoL index score (QALY weight) by the time spent in each health state. One QALY can be viewed as living for 1 year in the best possible health., 1 month; 6 months; 12 months; 24 months; 36 months|Survival Rate, Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status., 1 month; 6 months; 12 months; 24 months; 36 months
Other Outcome Measures: Clinically-driven target lesion revascularization (CD-TLR), Any surgical or percutaneous intervention to the target lesion(s) after the index procedure., 1 month; 6 months; 12 months; 24 months; 36 months|Wound healing, The wound diameter and ulcer grade., 1 month; 6 months; 12 months; 24 months; 36 months|Incremental cost effectiveness ratio (ICER), The difference in costs are divided by the difference in QALY or VascuQol., 1 month; 6 months; 12 months; 24 months; 36 months|Improvement of dietary and life style, The dietary habits and lifestyle of the patients were collected by questionnaire before operation. Before discharge, patients received education on healthy diet and lifestyle, and information on diet and lifestyle was collected at follow-up., 1 month; 6 months; 12 months; 24 months; 36 months|Cost effectiveness acceptability curve, It shows the probability of one treatment being more efficient in terms of QALYs than the other treatment for different levels of willingness to pay., 1 month; 6 months; 12 months; 24 months; 36 months|Ankle brachial index (ABI), The ratio of systolic pressure measured at the ankle artery to the brachial artery., 1 month; 6 months; 12 months; 24 months; 36 months