Status:
ACTIVE_NOT_RECRUITING
SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs
Lead Sponsor:
Yale University
Collaborating Sponsors:
University of Chicago
Oregon Health and Science University
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Brief Summary
A research project capturing experiences of patients with critical limb threatening ischemia, with the ultimate goal of setting new standards for diagnosing, describing detailed patient-centered outco...
Detailed Description
An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD). One of its extreme expressions is Critical Limb Ischemia (CLI). It is one of the most severe vascular c...
Eligibility Criteria
Inclusion
- All race/ethnicity categories, English speaking, men and women
- Patient presents with current (within 30 days) Rutherford Class 4, 5, or 6
- Age ≥18 years
- 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
- 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
- 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
- non-compressible ABI ≥ 1.40 AND TBI ≤ 0.70
- TBI\* ≤ 0.70
Exclusion
- Acute limb ischemia
- Unable to provide written informed consent
- Currently a prisoner (identified at time of enrollment)
Key Trial Info
Start Date :
August 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2028
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT04710563
Start Date
August 11 2021
End Date
September 1 2028
Last Update
October 20 2025
Active Locations (1)
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1
Yale New Haven Health
New Haven, Connecticut, United States, 06510