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

Peripheral Arterial Disease Clinical Trial

— SCOPE-CLI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04710563
• Other study ID #: 2000028963
• Secondary ID: 000
• Status: Recruiting
• Start date: August 11, 2021
• Est. completion date: September 2028

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Avis Harper Brooks, MA
• Phone: 203-737-7673
• Email: avis.harperbrooks[@]yale.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 conditions associated with devastating outcomes, including poorly healing wounds, extreme pain, and a high amputation risk. It is also one of the deadliest conditions, with 6-month and 5-year mortality rates estimated to be 20 and >50%, respectively. To date, however, there is a paucity of prospective clinical evidence about the variability in patients' presentations, their management or their outcomes. Accordingly, little progress has been made in adequately staging the disease and to risk-stratify treatment approaches to patients' individual characteristics. What is desperately needed to advance the care and management of patients with CLI is a focused research effort to set new standards for diagnosing, describing detailed patient-centered outcomes, and evaluating the variability in therapeutic approaches and their association with outcomes. The specific aims of SCOPE-CLI are to generate new evidence on the clinical characteristics, treatment patterns and outcomes of patients with critical limb ischemia (CLI); to describe treatment patterns and variability across practices to identify gaps in delivering quality care; and to perform a series of analyses to examine the associations of patient and treatment characteristics with outcomes. The central objective of SCOPE-CLI is to systematically quantify patients' CLI-specific health status and clinical outcomes and to perform subgroup analyses as a function of different PAD treatments and patient characteristics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 816
• Est. completion date: September 2028
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. 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 Criteria:

1. Acute limb ischemia

2. Unable to provide written informed consent

3. Currently a prisoner (identified at time of enrollment)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
United States	Yale New Haven Health	New Haven	Connecticut

Sponsors (14)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Major adverse limb events (MALE)	Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography)	6 months after enrollment
Secondary	Major adverse limb events (MALE)	Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography)	12 months after enrollment
Secondary	Major adverse limb events (MALE)	Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography)	5 years after enrollment
Secondary	Amputation Free Survival (AFS)	AFS will be a measure of number of patients "free from death or above ankle amputation"	6 months after enrollment
Secondary	Amputation Free Survival (AFS)	AFS will be a measure of number of patients "free from death or above ankle amputation"	12 months after enrollment
Secondary	Amputation Free Survival (AFS)	AFS will be a measure of number of patients "free from death or above ankle amputation"	5 years after enrollment
Secondary	Mortality - Death	Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died	6 months after enrollment
Secondary	Mortality - Death	Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died	12 months after enrollment
Secondary	Mortality - Death	Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died	5 years after enrollment