Arteriosclerosis Obliterans
Conditions
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.
Interventions
PROCEDUREopen 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.
PROCEDUREbare metal stent group
Bare metal stent implantation during the index procedure.
PROCEDUREplain old balloon angioplasty group
Only plain old balloon was used during the index procedure.
PROCEDUREdrug-coated balloon group
Drug-coated balloon was used during the index procedure.
PROCEDUREdirectional atherectomy group
Directional atherectomy (with or without drug-coated balloon) during the index procedure.
PROCEDUREhybrid 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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limb salvage rate | 1 month; 6 months; 12 months; 24 months; 36 months | Freedom from above ankle amputation in target limb. |
| Primary patency rate | 1 month; 6 months; 12 months; 24 months; 36 months | Primary patency of target lesion is assessed by the vascular ultrasound. |
| Major adverse limb event (MALE) rate | 1 month; 6 months; 12 months; 24 months; 36 months | Major adverse limb events include anyone of the following: Amputation in target limb and major re-intervention on target limb. |
| All cause mortality rate | 1 month; 6 months; 12 months; 24 months; 36 months | Death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Restenosis of the target lesion | 1 month; 6 months; 12 months; 24 months; 36 months | A peak systolic velocity ratio of over 2.4 measured using duplex ultrasound, \>50% diameter stenosis or occlusion by follow-up angiography. |
| Major adverse cardiovascular events (MACE) | 1 month; 6 months; 12 months; 24 months; 36 months | 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. |
| Quality-adjusted life-years (QALYs) | 1 month; 6 months; 12 months; 24 months; 36 months | 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. |
| Survival Rate | 1 month; 6 months; 12 months; 24 months; 36 months | Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status. |
Countries
China
Contacts
CONTACTHaoliang Wu
CONTACTZilun Li
PRINCIPAL_INVESTIGATORZilun Li
First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed