Risk Factors for Adverse Outcomes of Endovascular Revascularization in Lower Extremity Arteriosclerosis Occlusion: a Prospective Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

Arteriosclerosis obliterans (ASO) is one of the most common peripheral artery diseases (PADs) which causes ischemic symptoms of the lower limbs. Endovascular treatment has emerged as the most commonly used and efficient treatment option for PAD. However, adverse cardiovascular and lower extremity outcomes are inevitable, which remains a challenge for the vascular surgeon. ASO can be characterized by intermittent claudication, ischemic resting pain, and severe lower extremity ischemia. Known risk factors for lower extremity ASO include smoking, diabetes, hypertension, hyperlipidemia, hyperhomocysteinemia, chronic renal insufficiency, inflammatory indicators, etc. Endovascular revascularization is widely used at present. Many clinical centers choose endovascular therapy as the revascularization method of choice because of the lower incidence of complications and mortality compared with surgery, and the possibility of switching to open surgery if treatment fails. Luminal therapy is recommended when intermittent claudication affects quality of life, exercise or medical therapy is not effective, and clinical features suggest that endovascular therapy can improve the patient's symptoms and has a good risk benefit. At present, endovascular revascularization is widely used, but the incidence of adverse cardiovascular and lower extremity outcomes is still high, and the risk factors affecting the adverse outcomes after endovascular revascularization are still unclear. The aim of this study is to explore the risk factors affecting the poor outcome of endovascular revascularization for lower extremity ASO, and to provide precise prevention strategies for improving the prognosis of the patients. This study was designed as a single-center, prospective observational study. A total of 500 adult patients with lower extremity ASO who underwent endovascular revascularization in the Departments of Vascular Surgery and Peripheral Vascular in the First Affiliated Hospital of Xi'an Jiaotong University were enrolled as the study cohort. The exclusion criteria includes patients with severe infections, tumors, liver and kidney failure, autoimmune diseases, and incomplete baseline data. Demographic characteristics, comorbidities, and serum biochemical parameters were collected at baseline. The patients were followed up 1-3 years after interventional therapy. Follow-up included adverse cardiovascular events (cardiovascular death, acute myocardial infarction, stroke), lower extremity adverse events (resting pain, gangrene, amputation), and all-cause death. Multivariate COX regression analysis is used to analyze the influencing factors of poor prognosis in patients with lower extremity ASO undergoing endovascular revascularization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients with lower extremity arterial occlusive disease who underwent successful endovascular revascularization.

• Preoperative baseline clinical data were complete.

• Patients who completed the informed consent form.

Locations
Other Locations
China
First Affiliated Hospital of Xi 'an Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Qingbin Zhao, Doctor
zhaoqingbin05@163.com
0086-029-85324043
Time Frame
Start Date: 2022-10-20
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 500
Treatments
Patients with lower extremity arterial occlusion undergoing endovascular revascularization
We will enroll the patients with lower extremity arterial occlusive disease admitted to the Department of Vascular Surgery of The First Affiliated Hospital of Xi 'an Jiaotong University. These patients undergo successful endovascular revascularization of the diseased vessel.
Sponsors
Leads: First Affiliated Hospital Xi'an Jiaotong University

This content was sourced from clinicaltrials.gov

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