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.
