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A machine learning-based study of prognostic prediction model of endovascular therapy for lower limb extremity and validation on a prospective cohort

A machine learning-based study of prognostic prediction model of endovascular therapy for lower limb extremity and validation on a prospective cohort

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090215
Enrollment
Unknown
Registered
2024-09-26
Start date
2024-09-30
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lower extremity atherosclerotic occlusive disease

Interventions

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Retrospective cohort inclusion criteria Patients will be included in this study if they meet ALL of the following criteria: 1. Diagnosed with lower extremity atherosclerotic occlusive disease and admitted for endovascular treatment between January 2017 and December 2023. 2. Complete lower extremity CTA images before the procedure or complete DSA images saved during the procedure. 3. First-time endovascular intervention for the target lesion in a single limb. 4. Complete baseline information, surgical records, pre-discharge ABI results, and 2-year follow-up information and outcome indicators. 5. Signed informed consent for biospecimen donation, agreeing that the donated samples and related information can be used for all medical research. Prospective cohort inclusion criteria: Patients will be included in this study if they meet ALL of the following criteria: 1. Diagnosed with lower extremity atherosclerotic occlusive disease. 2. Complete lower extremity CTA images before the procedure or complete DSA images saved during the procedure. 3. First-time endovascular intervention for the target lesion in a single limb. 4. Complete baseline information, surgical records, and pre-discharge ABI results. 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: Retrospective cohort exclusion criteria: Patients will be excluded from this study if they have ANY of the following: 1. Severe heart, lung, or liver failure. 2. History of malignant tumor and not cured. 3. Life expectancy less than 2 years. 4. Unable to provide valid information on endpoint events. 5. Unable to provide complete medical history and follow-up endpoint events. Prospective cohort exclusion criteria: Patients will be excluded from this study if they have ANY of the following: 1. Severe heart, lung, or liver failure. 2. History of malignant tumor and currently active. 3. Life expectancy less than 2 years. 4. Unable to complete or tolerate examinations during follow-up. 5. Unable to provide complete medical history. 6. Unable to accept postoperative follow-up.

Design outcomes

Primary

MeasureTime frame
main adverse limb event;Recurrent worsening of ischemic symptoms in the target limb;Sensitivity;Specificity;Accuracy;positive predictive value ;negative predictive value ;

Secondary

MeasureTime frame
all-cause death;Target vessel-related death;cardiovascular adverse event;Cerebrovascular adverse event;

Countries

China

Contacts

Public ContactPan Tianyue

Zhongshan Hospital, Fudan University

tanyuepan@126.com+86 158 0080 2319

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026