Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

NCT ID: NCT06485622

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2029-07-31

Brief 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.

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.

Conditions

Arteriosclerosis Obliterans

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bypass group

open bypass group

open bypass group

Intervention Type: PROCEDURE

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

bare metal stent group

Intervention Type: PROCEDURE

Bare metal stent implantation during the index procedure.

POBA group

POBA (plain old balloon angioplasty) group

plain old balloon angioplasty group

Intervention Type: PROCEDURE

Only plain old balloon was used during the index procedure.

DCB group

drug-coated balloon group

drug-coated balloon group

Intervention Type: PROCEDURE

Drug-coated balloon was used during the index procedure.

DA group

DA (directional atherectomy) group

directional atherectomy group

Intervention Type: PROCEDURE

Directional atherectomy (with or without drug-coated balloon) during the index procedure.

HR group

HR (hybrid repair) group

hybrid repair group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

bare metal stent group

Bare metal stent implantation during the index procedure.

Intervention Type: PROCEDURE

plain old balloon angioplasty group

Only plain old balloon was used during the index procedure.

Intervention Type: PROCEDURE

drug-coated balloon group

Drug-coated balloon was used during the index procedure.

Intervention Type: PROCEDURE

directional atherectomy group

Directional atherectomy (with or without drug-coated balloon) during the index procedure.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Zilun Li

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zilun Li

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haoliang Wu

Role: CONTACT

wu18738957806@126.com

18738957806

Zilun Li

Role: CONTACT

lizilun@mail.sysu.edu.cn

13760871576

Facility Contacts

Zilun Li, Doctor

Role: primary

lizilun@mail.sysu.edu.cn

13760871576

References

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.

Reference Type: BACKGROUND

PMID: 28847660 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27853158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25523536 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34303802 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18673543 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22371308 (View on PubMed)

Other Identifiers

[2024]225

Identifier Type: -

Identifier Source: org_study_id