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.
SCOPE-CLI: Shifting Care and Outcomes for Patients with Endangered limbs Critical Limb Ischemia
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.
Ongoing VAMOS Studies
- Diseases of the Cardiovascular SystemCRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral LesionsPrincipal Investigator: Kim Germaine Emiel Smolderen
- Diseases of the Cardiovascular SystemSCOPE-CLI: Shifting Care and Outcomes for Patients with Endangered limbs Critical Limb IschemiaPrincipal Investigator: Kim Germaine Emiel Smolderen
- Mental Health & Behavioral ResearchStress, Sleep and Arterial StiffnessPrincipal Investigator: Matthew BurgNot accepting volunteers
- Diseases of the Cardiovascular SystemCarotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)Principal Investigator: Carlos Mena-Hurtado
- COVID-19 Inpatient, COVID-19 OutpatientTelehealth Care Experiences in Yale New Haven Health System Patients and Providers in Times of COVID-19Principal Investigator: Kim Germaine Emiel SmolderenNot accepting volunteers