Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arteriosclerosis Obliterans
• Intervention / Treatment: 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

Detailed Description

Arteriosclerosis obliterans (ASO) is a kind of lower extremity arterial disease which occurs frequently in middle-aged and elderly people. The incidence of ASO increases with age. In patients with ASO, the build-up of fatty deposits, cholesterol, and other substances (plaques) in the arteries reduces blood flow to the extremities. This can lead to symptoms such as leg pain, cramping, and fatigue, especially during physical activity. In severe cases, it may result in pain at rest, non-healing wounds, and complications such as tissue damage or infection. Chronic wound is one of the symptoms that affect the quality of life. Therefore, wound healing is also an important index for postoperative care. However, no study has reported detailed performance data for different treatments. As an auxiliary method in clinical treatment, nutrition plays an important role in improving the clinical outcome of patients in the development and postoperative stages of the disease. The effect of nutritional risk assessment and nutritional education on postoperative symptoms of ASO has not been reported. Therefore, we plan to carry out this prospective, single-center, observational study, providing new data on the efficacy, safety and cost-effectiveness for different treatment and assistive techniques in lower extremity arterial occlusive disease.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Haoliang Wu; Phone Number: 18738957806; Email: wu18738957806@126.com
• Study Contact Backup: Name: Zilun Li; Phone Number: 13760871576; Email: lizilun@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-Sen University
      • Contact: Zilun Li, Doctor; Phone Number: 13760871576; Email: lizilun@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

lower extremity arteriosclerosis obliterans

Description

Inclusion Criteria:

1. Age 18 years or older, gender is not limited.
2. Patients diagnosed with arteriosclerosis obliterans.
3. Rutherford stages 2-6.
4. When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
5. Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included.

Exclusion Criteria:

1. Malignant tumor
2. Alzheimer's disease
3. Blood disease or bleeding tendency
4. Heart Failure Grade III ~ IV
5. Pregnancy or lactation
6. An above-knee-below-knee amputation has been performed
7. Unable to accept therapeutic function tests
8. Life expectancy is less than six months
9. Combined with other diseases affecting walking
10. Cardiovascular and cerebrovascular events occurred within 3 months, including non-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemic stroke and hemorrhagic stroke
11. Patients with significant abnormal liver and renal function that the investigators judged to be clinically significant

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bypass group; open bypass group	Procedure: open bypass group; After heparinization, the target artery is clamped above and below the anastomosis. The target artery is dissected along the anterior wall, calcium portions or mural thrombus are removed. Graft (autologous or prosthetic graft) is cut obliquely and anastomosis suturing starts with distal angle. Next stage is tunnel creating for graft conduction.
BMS group; BMS (bare metal stent) group	Procedure: bare metal stent group; Bare metal stent implantation during the index procedure.
POBA group; POBA (plain old balloon angioplasty) group	Procedure: plain old balloon angioplasty group; Only plain old balloon was used during the index procedure.
DCB group; drug-coated balloon group	Procedure: drug-coated balloon group; Drug-coated balloon was used during the index procedure.
DA group; DA (directional atherectomy) group	Procedure: directional atherectomy group; Directional atherectomy (with or without drug-coated balloon) during the index procedure.
HR group; HR (hybrid repair) group	Procedure: hybrid repair group; Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. Arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Endovascular revascularization followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Zilun Li, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

General Publications

• Scully RE, Arnaoutakis DJ, DeBord Smith A, Semel M, Nguyen LL. Estimated annual health care expenditures in individuals with peripheral arterial disease. J Vasc Surg. 2018 Feb;67(2):558-567. doi: 10.1016/j.jvs.2017.06.102. Epub 2017 Aug 25.
• Fowkes FG, Aboyans V, Fowkes FJ, McDermott MM, Sampson UK, Criqui MH. Peripheral artery disease: epidemiology and global perspectives. Nat Rev Cardiol. 2017 Mar;14(3):156-170. doi: 10.1038/nrcardio.2016.179. Epub 2016 Nov 17.
• Gupta R, Siada S, Lai S, Al-Musawi M, Malgor EA, Jacobs DL, Malgor RD. Critical appraisal of the contemporary use of atherectomy to treat femoropopliteal atherosclerotic disease. J Vasc Surg. 2022 Feb;75(2):697-708.e9. doi: 10.1016/j.jvs.2021.07.106. Epub 2021 Jul 22.
• Fu S, Zhao H, Shi J, Abzhanov A, Crawford K, Ohno-Machado L, Zhou J, Du Y, Kuo WP, Zhang J, Jiang M, Jin JG. Peripheral arterial occlusive disease: global gene expression analyses suggest a major role for immune and inflammatory responses. BMC Genomics. 2008 Aug 1;9:369. doi: 10.1186/1471-2164-9-369.
• Folkersen L, Persson J, Ekstrand J, Agardh HE, Hansson GK, Gabrielsen A, Hedin U, Paulsson-Berne G. Prediction of ischemic events on the basis of transcriptomic and genomic profiling in patients undergoing carotid endarterectomy. Mol Med. 2012 May 9;18(1):669-75. doi: 10.2119/molmed.2011.00479.
• Soga Y, Iida O, Takahara M, Hirano K, Suzuki K, Kawasaki D, Miyashita Y, Tsuchiya T. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014 Dec;7(12):1444-9. doi: 10.1016/j.jcin.2014.06.018.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Arteriosclerosis; Arteriosclerosis Obliterans
• Other Study ID Numbers: [2024]225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No