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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open bypass group | 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. |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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lower extremity arteriosclerosis obliterans
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haoliang Wu | Contact | 18738957806 | wu18738957806@126.com | |
| Zilun Li | Contact | 13760871576 | lizilun@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zilun Li | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28847660 | Background | 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. | |
| 27853158 | Background | 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. |
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|
| bare metal stent group | Procedure | Bare metal stent implantation during the index procedure. |
|
| plain old balloon angioplasty group | Procedure | Only plain old balloon was used during the index procedure. |
|
| drug-coated balloon group | Procedure | Drug-coated balloon was used during the index procedure. |
|
| directional atherectomy group | Procedure | Directional atherectomy (with or without drug-coated balloon) during the index procedure. |
|
| hybrid repair group | 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. |
|
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 |
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 |
| 25523536 | Background | 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. |
| 34303802 | Background | 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. |
| 18673543 | Background | 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. |
| 22371308 | Background | 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. |
| ID | Term |
|---|---|
| D001162 | Arteriosclerosis Obliterans |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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