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. 2022 Feb 12;39:100971. doi: 10.1016/j.ijcha.2022.100971

Table 2.

Overview of SCOPE-CLI Inclusion and Exclusion Criteria.

Inclusion Criteria Exclusion Criteria
  • 1.

    Age ≥ 18 years

  • 1.

    Acute limb ischemia

  • 2.

    ABI and TBI performed within the last 6 months (if patient undergoes revascularization, patient can be enrolled if a pre-procedural ABI/TBI is available)

  • 2.

    Currently a prisoner

  • 3.

    Patient presents with current (within 30 days) Rutherford Class 4, 5, or 6 as defined as any of the following:

  • -

    Rutherford Classification 4 or ischemic rest pain or resting ankle pressure < 50 mmHg, flat or barely pulsatile ankle or metatarsal PVR or toe pressure < 40 mmHg

  • -

    Rutherford Classification 5 or minor tissue loss; non-healing ulcer, focal gangrene with diffuse pedal ischemia or resting ankle pressure < 50 mmHg, or flat or barely pulsatile ankle or metatarsal PVR, or toe pressure < 40 mmHg

  • -

    Rutherford Classification 6 or major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable or resting ankle pressure < 50 mmHg, or flat or barely pulsatile ankle or metatarsal PVR, or toe pressure < 40 mmHg

  • -

    CLI related ICD 10 code (reason for admission or indication for procedure)

  • -
    Documentation of any of the following diagnostic evidence:
    • i.
      SPP < 50 mmHg
    • ii.
      TCPO2 < 50 mmHg
    • iii.
      Angiographic evidence no straight line to foot or>70% stenosis in all 3 lower extremity arteries (AT, PT, peroneal)
    • iv.
      ABI* ≤ 0.90
    • v.
      Non-compressible ABI ≥ 1.40 AND TBI ≤ 0.70
    • vi.
      TBI* ≤ 0.70
  • 3.

    Unable to provide written informed consent

  • 4.

    English or Spanish speaking

(*) These diagnostic testing results must be present to enter the study.

Abbreviations: ABI, Ankle Brachial Index; AT, anterior tibial; ICD, International Classification of Diseases; PT, posterior tibial, PVR, Pulse Volume Recording; SPP, skin perfusion pressure; TBI, toe brachial index; TCPO2, transcutaneous oximetry