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To construct an AI-based multimodal biomarker model for predicting restenosis after peripheral artery disease treatment

To construct an AI-based multimodal biomarker model for predicting restenosis after peripheral artery disease treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118257
Enrollment
Unknown
Registered
2026-02-03
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Peripheral vascular disease

Interventions

Training set:None

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: Phase I Study (Multicenter Retrospective Study, Experimental Cohort) Inclusion criteria: Age >= 35 years;Patients with chronic lower limb ischemia who underwent interventional surgery;Having preoperative lower limb CTA imaging results and blood samples. Phase II Study (Multicenter Prospective Study, Validation Cohort) Inclusion criteria: Age >= 35 years;Chronic lower limb ischemia at Rutherford stage 3-5;Undergoing interventional therapy;Patients who provided informed consent for enrollment;Capable of completing optimal medical treatment.

Exclusion criteria

Exclusion criteria: Phase I Study (Multicenter Retrospective Study, Experimental Cohort) Exclusion criteria: Patients with a history of lower limb amputation;Acute lower limb ischemia;Poor quality of CTA images that affects the interpretation of the observation area;Lack of blood samples or incomplete relevant case data required for the study. Phase II Study (Multicenter Prospective Study, Validation Cohort) Exclusion criteria: Age < 35 years;Acute lower limb ischemia;Chronic lower limb ischemia at Rutherford stage 6;Patients with a history of lower limb amputation;Patients scheduled to undergo lower limb amputation surgery;Patients scheduled to undergo open bypass surgery;Inability to complete CTA examination;Inability to cooperate with follow-up;Contrast medium contraindication; Hepatic and renal insufficiency.

Design outcomes

Primary

MeasureTime frame
Blood routine examination;Blood biochemistry;Coagulation Function;Ankle-Brachial Index;Electrocardiogram;Quality of Life (QoL) Scale Score;Adverse Limb Events;Degree of Stenosis of vessel; Plaque Burden;Plasma Metabolomics;Plasma Proteomics;Basic Information Related to Surgery;Basic Information Related to Anesthesia;Surgery and Anesthesia-Related Complications;Duration of Hospitalization;Hospitalization Expenses;Cardiovascular and Cerebrovascular Events;Systemic Complications;Adverse Limb Events;Medication During the Follow-Up Period;Symptom Recurrence;Target Vessel Patency;Healing Status of Lower Extremity Gangrene and Ulcers;Amputation Status;Time for Five Sit-Ups;6-Minute Walk Test;Death event;Indicators for Lower Extremity Muscles;Area under the ROC curve;

Secondary

MeasureTime frame
Calibration Curve;Positive Predictive Value;Negative Predictive Value;

Countries

China

Contacts

Public ContactDiao Yongpeng

Beijing Hospital

sunheartdyp@163.com+86 135 8161 1275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026