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There has been very little clinical evidence to date about the variability in patients’ presentations, their socio-economic and psychosocial characteristics, and associations with their management or their outcomes. We hope this will provide us with much needed insights for the field.

Kim Smolderen, PhD

Highlighted Studies

SCOPE-CLI: Shifting Care and Outcomes for Patients with Endangered limbs Critical Limb Ischemia

An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD). One of its extreme expression 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 above 50% respectively.

The SCOPE-CLI is made up of 12 centers including Yale New Haven Hospital. The registry will enroll and interview 816 patients from multidisciplinary vascular centers in the United States. Patients will be followed up at 1, 2, 6, and 12 months. During their regular visits to their doctors, study staff will collect information regarding psychosocial factors and health status from interviews and treatments of patients who have severely clogged arteries to learn about their outcomes.

The overall goal of the SCOPE-CLI study is to document the difference in treatment approaches and examine the associations of patient and treatment characteristics with outcomes. The researchers hope to determine whether improved quality of care can be traced to improved health status, fewer amputations, and other adverse limb events.

Comparison of VASCADE Closure vs Manual Compression for Severely Diseased Common Femoral Arterial Access Sites

Patients with peripheral artery disease are at higher risk of complications from use of vascular closure device (VCDs) after interventional procedures. The Real-World Use study aims to describe the patient characteristics and outcomes by use of VASCADE closure device v.s. manual compression (MC) for hemostasis in patients undergoing peripheral vascular interventions (PVI) from a large single center database at Yale New Haven Health as a way to facilitate real-world comparative effectiveness research. Propensity score matching methodology will account for baseline differences in between treatment groups is feasible and will allow for future real-world comparative effectiveness research on VCDs in this higher risk cohort.


The primary objective of this study is to evaluate the generic health status outcomes and efficacy and safety outcomes following use of the Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with PAD seen in routine clinical practice.

Our main testable hypothesis is that the use of IVL is associated with a health status improvement that is equal or higher than the threshold of a minimally clinically important difference on the EQ5D. We will derive preliminarily data for the primary endpoint target lesion revascularization to enable future planning of larger comparative effectiveness research.

Pain Management Strategies, Associated Psychological Variables, and Outcomes in Critical Limb Ischemia (1R21AT012430-01)

Carlos Mena-Hurtado, MD and Kim Smolderen, PhD (M-PIs)

A growing number of Americans – over 2 million – are affected by critical limb ischemia (CLI), the most severe expression of peripheral artery disease (PAD). CLI is an extremely painful condition characterized by ischemic pain, non-healing wounds or ulcers, or gangrenous tissues. While mortality and amputation burden is substantial, the majority of patients survives the year following diagnosis and more and more emphasis is being placed on shifting the focus of endpoints from avoiding limb loss and mortality to living with CLI and improving patients’ health status and quality of life. The majority of patients with CLI reports chronic pain, which may have a great impact on patients’ health status and quality of life. As CLI care is fragmented, with multiple specialties involved, concerted pain management efforts are lacking and amputation is often offered as one of the ways in which chronic pain is currently managed. Supported by insights based on the gate-control theory of pain, both medical and psychological interventions are effective options to manage chronic pain in medical populations. The phenomenology of pain, pain management approaches, and its impact on CLI outcomes, however, is poorly understood. The long-term goal of our program is to create an integrated, patient-centered, and multimodal pain management program for CLI. As a first step, we aim to study the medical pain management approaches of CLI over time, and its association with CLI outcomes across the lifespan. Specifically, we aim to examine the longitudinal patterns of pain medication utilization in CLI and PAD and its association with outcomes (readmission/amputation/depression/anxiety) in national claims-based datasets as well as in a Medicare linked national vascular registry. We hypothesize that the use of pain medications, including opioids, over time is higher in CLI than a control PAD (non-CLI) population; and that patterns of high opioid use differ by CLI intervention strategy (non-invasive, revascularization, or amputation); and that high opioid use in CLI and PAD is associated with a higher risk of readmission, amputation, mortality, and depression/anxiety. In addition, through the patient-centered SCOPE-CLI registry, we will study proxies of the HEAL common data elements through general structured equation models that will help provide insights as to how pain impacts related behavioral domains and functioning and treatment satisfaction. We hypothesize that more severe pain experiences, are associated with higher levels of depression, anxiety, distress, and worse health status and CLI treatment satisfaction. The empirical data generated from this program of research will identify current gaps in pain management strategies and interactions with CLI care, functioning, and outcomes that will further guide the design of future research on care innovations and the integration of holistic CLI pain management strategies.

Ongoing VAMOS Studies