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INFORMATION FOR

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.

CRUSH PAD

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.

Ongoing VAMOS Studies