Arteriosclerosis Obliterans
Conditions
Interventions
Training set:None
Validation set:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Objective evidence for ASO diagnosis (one of the following + symptoms): (1)ABI = 20% or ankle pressure drops by > 30 mmHg; (3)Accompanied by corresponding symptoms and signs (such as intermittent claudication, rest pain, or tissue loss/non-healing ulcers of the limb), which can be recorded according to the Rutherford classification (grades 1–6). 2.First-time undergoing lower extremity arterial endovascular treatment: The relevant treatment in this study is the first endovascular revascularization performed on the target lesion (including balloon angioplasty, drug-coated balloon/stent, bare-metal stent, atherectomy, etc.). Patients with prior surgical bypass or previous endovascular revascularization are excluded. 3. Adequate follow-up plan and data: Scheduled imaging follow-up with CTA or DUS completed at 12 ± 3 months postoperatively to assess patency/restenosis/re-occlusion; and at least one outpatient review (including symptom classification and ABI/TBI measurements).
Exclusion criteria
Exclusion criteria: 1.Loss to Follow-Up or Insufficient Data Patients lost to follow-up or with missing key data (unable to obtain imaging evaluation at 12 ± 3 months postoperatively); or imaging quality insufficient to determine patency. 2. Acute Limb Ischemia (ALI) Defined as acute onset (symptoms <=14 days, limb viability threatened) requiring urgent intervention and unsuitable for inclusion in a stable follow-up cohort (based on clinical assessment at enrollment). 3. Severe Comorbidities Affecting Outcomes Active malignancy or expected survival <1 year, or treatment processes that may significantly affect limb outcomes (e.g., chemotherapy-induced vascular events), to avoid confounding. 4. Prior Relevant Treatment History Previous endovascular or surgical bypass revascularization prior to enrollment (cannot be evaluated as "first-time treatment"). Note: If CTA cannot be performed due to renal insufficiency, DUS may be used as an equivalent follow-up tool. Therefore, eGFR limitations are not set as an exclusion criterion (in order to reduce unnecessary selection bias).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis of lower extremity arteries is defined as a stenosis rate of =50% in the target lesion confirmed by ultrasound or CTA at 12 months postoperatively.;Model Evaluation Metrics (such as AUC, Calibration, Brier Score, and DCA); | — |
Countries
China
Contacts
Public ContactZhang Zhiwei
Shanghai General Hospital
Outcome results
None listed