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SCOPE-CLI: Shifting Care and Outcomes for Patients with Endangered limbs Critical Limb Ischemia

  • Study HIC#:2000028963
  • Last Updated:07/15/2021

The purpose of this research study is to collect information about the symptoms and treatments of patients who have severely clogged arteries and to learn about their outcomes at one year.

  • Age19 years and older
  • GenderBoth
  • Start Date04/16/2021
  • End Date09/30/2022

Eligibility Criteria

Inclusion Criteria

  1. All race/ethnicity categories, English speaking, men and women
  2. Patient presents with current (within 30 days) Rutherford Class 4, 5, or 6
  3. Age ≥18 years
  4. Medically stable
    • Supported by any of the following diagnostic evidence:
    • Rutherford Classification 4 or ischemic rest pain and/or resting ankle pressure <50mmHg, flat or barely pulsatile ankle or metatarsal PVR or toe pressure <40mmHg
    • Rutherford Classification 5 or minor tissue loss; non-healing ulcer, focal gangrene with diffuse pedal ischemia resting ankle pressure <50mmHg ankle or metatarsal PVR flat or barely pulsatile or toe pressure <40mmHg
    • CLI related ICD 10 code (reason for admission or indication for procedure)
    • SPP < 50 mmHg
    • TCPO2 < 50 mmHg
    • Angiographic evidence no straight line to foot or greater than 70% stenosis in all 3 lower extremity arteries (AT, PT, peroneal)
    • ABI* ≤ 0.90

Exclusion

  1. Acute limb ischemia
  2. Currently a prisoner
  3. Unable to provide informed consent

Principal Investigator

Sub-Investigator

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