SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs (NCT04710563)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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. Supported by any of the following diagnostic evidence:
5. 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
6. 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
7. Rutherford Classification 6 or major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable, resting ankle pressure \<50mmHg ankle or metatarsal PVR flat or barely pulsatile or toe pressure \<40mmHg
8. CLI related ICD 10 code (reason for admission or indication for procedure)
9. SPP \< 50 mmHg
10. TCPO2 \< 50 mmHg
11. Angiographic evidence no straight line to foot or greater than 70% stenosis in all 3 lower extremity arteries (AT, PT, peroneal)
12. ABI\* ≤ 0.90

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Yale New Haven Health — New Haven, Connecticut

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.