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Real-world outcomes study targets patients undergoing intravascular lithotripsy treatment at Yale

December 09, 2021
by Elisabeth Reitman

An observational study at the Yale New Haven Hospital (YNHH) Heart and Vascular Center could have major implications for patients with peripheral artery disease or PAD.

The CRUSH PAD real-world outcomes study, co-led by Carlos Mena-Hurtado, MD and Kim Smolderen, PhD, will recruit 50 participants from YNHH and University Hospitals Cleveland Medical Center with calcified PAD to determine if Intravascular Lithotripsy (IVL) technology is associated with improved quality of life and other health outcomes in calcified common femoral lesions.

PAD is a common condition which affects an estimated 8.5 million U.S. adults. Over time, a buildup of plaque inside the arteries may lead to calcium deposits or calcifications, making it difficult to open the blocked artery. Shockwave’s IVL is a noninvasive therapy designed to remove these deposits from the impacted artery. The device uses a balloon to deliver sonic pressure waves that can pass through soft arterial tissue to remove calcified plaque and optimize stent placement.

“Patients with critical limb ischemia have limited treatment options. Intravascular Lithotripsy is designed to address this urgent clinical need for patients with severely calcified PAD,” said Mena, an associate professor at the Yale School of Medicine and co-director of the Vascular Outcomes Program.

Previous clinical trial data on IVL has been promising. A 2019 study published in Circulation: Cardiovascular Interventions and a 2021 study in JACC: Cardiovascular Interventions showed minimal complications in patients with severe coronary artery and femoropopliteal artery calcification, respectively. CRUSH PAD will expand on this research by focusing on patients who experience severe PAD or critical limb ischemia (CLI) in the lower limbs. The study will focus on novel patient-centric health status outcomes as well as traditional freedom from target lesion revascularization outcomes.

Specifically, the CRUSH PAD research team will conduct patient interviews 30 days, 6 months, and 12 months following the procedure, and collect information on their medical follow-up. Clinical outcomes data will inform patients and clinicians as to what expect from a patient-centered perspective, as well as for the risk of potential complications such as restenosis or major adverse limb events following the procedure.

“Patients with CLI often present with multiple comorbidities or risk factors that can severely reduce their quality of life. By evaluating real-world outcomes, we hope to generate patient-centered outcomes as well as clinical outcomes data that may inform the quality of the medical decision making as well as future trials for these very complex patients,” said Smolderen, an associate professor at the Yale School of Medicine and co-director of the Vascular Outcomes Program.

The Vascular Medicine Outcomes (VAMOS) research program’s mission is to serve communities by improving vascular health outcomes. To learn more, please visit the VAMOS website or follow them on Twitter.

Submitted by Elisabeth Reitman on December 09, 2021