Peripheral Arterial DiseaseSCOPE-CLINCT04710563
SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs
An observational study of Peripheral Arterial Disease, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2021to Sep 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Acute limb ischemia
- Unable to provide written informed consent
- Currently a prisoner (identified at time of enrollment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia
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.
Read the 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 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.
- Conditions
- Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Artery Questionnaire (PAQ)
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After enrollment and follow-up at month 12
Secondary outcomes (9)
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)
Measured: 6 months after enrollment
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)
Measured: 12 months after enrollment
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)
Measured: 5 years after enrollment
Amputation Free Survival (AFS)
AFS will be a measure of number of patients "free from death or above ankle amputation"
Measured: 6 months after enrollment
Amputation Free Survival (AFS)
AFS will be a measure of number of patients "free from death or above ankle amputation"
Measured: 12 months after enrollment
Amputation Free Survival (AFS)
AFS will be a measure of number of patients "free from death or above ankle amputation"
Measured: 5 years after enrollment
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
Measured: 6 months after enrollment
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
Measured: 12 months after enrollment
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
Measured: 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start11 Aug 2021
- Primary completion31 Dec 2024
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 458 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Oregon Health and Science University, University of California, Davis, University of Southern California, Baylor College of Medicine, The Cleveland Clinic, Emory University, Brown University, Columbia University, University of Minnesota, Saint Luke's Health System, Abbott, Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Kim Smolderen, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710563
- Sponsor's protocol ID
- 2000028963
- Other IDs
- 000
- Acronym
- SCOPE-CLI
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2021
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35198727
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT04710563
- Acronym / sponsor ID
- SCOPE-CLI / 2000028963
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Chicago, Oregon Health and Science University, University of California, Davis, University of Southern California, Baylor College of Medicine, The Cleveland Clinic, Emory University, Brown University, Columbia University, University of Minnesota, Saint Luke's Health System, Abbott, Janssen Scientific Affairs, LLC
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (3 listed)
- Acute limb ischemia
- Unable to provide written informed consent
- Currently a prisoner (identified at time of enrollment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral Artery Questionnaire (PAQ)
Time frame: After enrollment and follow-up at month 1
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
Peripheral Artery Questionnaire (PAQ)
Time frame: After enrollment and follow-up at month 2
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
Peripheral Artery Questionnaire (PAQ)
Time frame: After enrollment and follow-up at month 6
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
Peripheral Artery Questionnaire (PAQ)
Time frame: After enrollment and follow-up at month 12
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
9 secondary outcomes
Major adverse limb events (MALE)
Time frame: 6 months after enrollment
Major adverse limb events (MALE)
Time frame: 12 months after enrollment
Major adverse limb events (MALE)
Time frame: 5 years after enrollment
Amputation Free Survival (AFS)
Time frame: 6 months after enrollment
Amputation Free Survival (AFS)
Time frame: 12 months after enrollment
Amputation Free Survival (AFS)
Time frame: 5 years after enrollment
Mortality - Death
Time frame: 6 months after enrollment
Mortality - Death
Time frame: 12 months after enrollment
Mortality - Death
Time frame: 5 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Derived from this study: PubMed 35198727Scierka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Smolderen, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Artery Questionnaire (PAQ) (time frame: After enrollment and follow-up at month 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.