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

NCT05586022 | Recruiting

• 1 other identifier: XJTU1AF2022LSK-346
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• adverse cardiovascular events

  cardiovascular death, acute myocardial infarction, stroke

  Patients were followed up from the day of endovascular revascularization to 1 year after operation

Study Arms (1)

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.

Procedure: endovascular revascularization

Interventions

endovascular revascularization PROCEDURE

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

Patients with lower extremity arterial occlusion undergoing endovascular revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included adult patients with lower extremity arterial occlusive disease who had successfully undergone endovascular revascularization in the First Affiliated Hospital of Xi 'an Jiaotong University. These patients had complete preoperative baseline data including demographic characteristics, comorbidities, and related blood biochemical indicators, and signed informed consent to accept follow-up.

You may qualify if:

• 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.

You may not qualify if:

• Patients with severe infections, tumors, liver and kidney failure, and autoimmune diseases.
• Patients with incomplete baseline data.
• Patients lost to follow-up.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting 10 mL blood samples from participants are collected for the detection of blood biochemical indicators, such as myocardial enzymes, troponin, liver function, kidney function, blood lipids, etc.

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

• Qingbin Zhao, Doctor

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingbin Zhao, Doctor

CONTACT

0086-029-85324043; zhaoqingbin05@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: October 20, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)