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Risk Factors for Adverse Outcomes of Endovascular Revascularization in Lower Extremity Arteriosclerosis Occlusion

NCT05586022 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

PROCEDURE

endovascular revascularization

percutaneous balloon dilatation, stent implantation, plaque resection, laser plasty, cutting balloon, drug balloon, cryoballoplasty, thrombolytic therapy with drugs or thrombectomy

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Qingbin Zhao, Doctor · First Affiliated Hospital of Xi 'an Jiaotong University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586022 on ClinicalTrials.gov