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NCT Number: NCT03171259

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

Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are relevant to patients and clinicians. To address this need, the current study will pilot test the research infrastructure and data elements needed to build a larger, national study collecting of the CLI population. It will also provide much-needed preliminary information to identify areas of action that can be targeted in quality improvement programs for this population. Most importantly, it will provide data on health status outcomes in patients with CLI, as a function of individual patient characteristics (demographics, socio-economic and clinical background) and the treatments that patients have undergone. The PORTRAIT-CLI study will also be well equipped to identify potential disparities in the provision of care and patients' outcomes as a function of patient's characteristics.

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All race/ethnicity categories, English or Spanish speaking, men and women

  • Age ≥18 years
  • Patients presenting with Rutherford Classification 4 (ischemic rest pain), or Rutherford Classification 5 (minor tissue loss: non-healing ulcer, focal gangrene with diffuse pedal ischemia), or Rutherford Classification 6 (major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable) at specialty clinics will prospectively be screened, regardless of whether the patient undergoes endovascular, bypass, amputation, and/or medical therapy.
  • Diagnosis is supported by any of the following hemodynamic parameters (assessed pre- procedurally): Ankle pressure lower than 70 mmHg; Toe pressure lower than 50 mmHg or evidence of ischemia by transcutaneous oxygen measurement (tcpO2) <40 or a skin perfusion pressure (SPP) <40 or angiographic evidence of significant vascular disease

Exclusion criteria

  • No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the enrollment
  • Acute limb ischemia
  • Unable to provide written informed consent
  • Currently a prisoner

Treatment and study plan

Care as usual

Other

The investigators will be following patients with critical limb ischemia and documenting the usual care that the participants receive.

Primary outcomes

  1. CLI-specific health status

    Time frame: 12 months

    Peripheral Artery Questionnaire-CLI version

Secondary outcomes

  1. Freedom from major amputation or major reintervention

    Time frame: 12 months

    Freedom from major amputation or major peripheral vascular reintervention (surgical or angioplasty)

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: SCOPE CLI

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 31, 2017
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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