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

NCT04710563 | Active Not Recruiting DMC

• 2 other identifiers: 2000028963000
• Study Type: observational
• Target: 458
• Locations: 1 country
• Sites: 1

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 outcomes, and evaluating the variability in therapeutic approaches and their association with outcomes.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (4)

• Peripheral Artery Questionnaire (PAQ)

  PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.

  After enrollment and follow-up at month 1

• Peripheral Artery Questionnaire (PAQ)

  PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.

  After enrollment and follow-up at month 2

• Peripheral Artery Questionnaire (PAQ)

  PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.

  After enrollment and follow-up at month 6

• Peripheral Artery Questionnaire (PAQ)

  PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.

  After enrollment and follow-up at month 12

Secondary Outcomes (9)

• Major adverse limb events (MALE)

  6 months after enrollment

• Major adverse limb events (MALE)

  12 months after enrollment

• Major adverse limb events (MALE)

  5 years after enrollment

• Amputation Free Survival (AFS)

  6 months after enrollment

• Amputation Free Survival (AFS)

  12 months after enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled from a range of clinical practices combining forces from vascular surgery, vascular medicine (interventional) cardiology, wound care specialists and podiatry clinics that treat CLI patients. All patients will be medically stable, i.e., not actively experiencing a life-threatening critical condition for which emergent care processes are ongoing, before they are approached for inclusion in the study.

You may qualify if:

• 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

You may not qualify if:

• Acute limb ischemia
• Unable to provide written informed consent
• Currently a prisoner (identified at time of enrollment)

Sponsors & Collaborators

• Yale University: lead
• University of Chicago: collaborator
• Oregon Health and Science University: collaborator
• University of California, Davis: collaborator
• University of Southern California: collaborator
• Baylor College of Medicine: collaborator
• The Cleveland Clinic: collaborator
• Emory University: collaborator
• Brown University: collaborator
• Columbia University: collaborator
• University of Minnesota: collaborator
• Saint Luke's Health System: collaborator
• Abbott: collaborator
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Yale New Haven Health

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Scierka LE, Mena-Hurtado C, Shishehbor MH, Spertus JA, Nagpal S, Babrowski T, Bunte MC, Politano A, Humphries M, Chung J, Kirksey L, Alabi O, Soukas P, Parikh S, Faizer R, Fitridge R, Provance J, Romain G, McMillan N, Stone N, Scott K, Fuss C, Pacheco CM, Gosch K, Harper-Brooks A, Smolderen KG; SCOPE-CLI Academic Research Consortium. The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale. Int J Cardiol Heart Vasc. 2022 Feb 12;39:100971. doi: 10.1016/j.ijcha.2022.100971. eCollection 2022 Apr.

  PMID: 35198727 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Kim Smolderen, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 14, 2021
• Study Start: August 11, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)