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.
