Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

Official title

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

Overview

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.

Interventions

• 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.
• Procedure bare metal stent group
  Bare metal stent implantation during the index procedure.
• Procedure plain old balloon angioplasty group
  Only plain old balloon was used during the index procedure.
• Procedure drug-coated balloon group
  Drug-coated balloon was used during the index procedure.
• Procedure directional atherectomy group
  Directional atherectomy (with or without drug-coated balloon) during the index procedure.
• 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.

Primary outcome measures

• Limb salvage rate [Time frame: 1 month; 6 months; 12 months; 24 months; 36 months]
• Primary patency rate [Time frame: 1 month; 6 months; 12 months; 24 months; 36 months]
• Major adverse limb event (MALE) rate [Time frame: 1 month; 6 months; 12 months; 24 months; 36 months]
• All cause mortality rate [Time frame: 1 month; 6 months; 12 months; 24 months; 36 months]

Secondary outcome measures (4)

• Restenosis of the target lesion [Time frame: 1 month; 6 months; 12 months; 24 months; 36 months]
• Major adverse cardiovascular events (MACE) [Time frame: 1 month; 6 months; 12 months; 24 months; 36 months]
• Quality-adjusted life-years (QALYs) [Time frame: 1 month; 6 months; 12 months; 24 months; 36 months]
• Survival Rate [Time frame: 1 month; 6 months; 12 months; 24 months; 36 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou

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. PMID 28847660
• 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. PMID 27853158
• 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. PMID 25523536
• 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. PMID 34303802
• 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. PMID 18673543
• 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. PMID 22371308

Identifiers

NCT: NCT06485622 · [2024]225

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗