Enrollment Begins in REACH PVI Study of CSI's Transradial Orbital Atherectomy Devices
June 11, 2019—Cardiovascular Systems, Inc. (CSI) announced that the first patient was enrolled in the REACH PVI study. The study aims to evaluate acute clinical outcomes of orbital atherectomy via transradial access for the treatment of peripheral artery disease (PAD) in lower extremity lesions with CSI’s low-profile 5-F extended-length Diamondback 360 peripheral orbital atherectomy system (OAS) and extended-length Stealth 360 peripheral OAS. The CSI orbital atherectomy devices used in the study are FDA-cleared for the treatment of PAD.
The REACH PVI study is a prospective, observational, single-arm, multicenter postmarket study that will enroll 50 patients at up to 10 sites across the United States. All patients will be followed postprocedure through the first standard-of-care follow-up visit (7–45 days postprocedure).
Ankur Lodha, MD, is the National Primary Investigator for REACH PVI and enrolled the first patient. In CSI's announcement, Dr. Lodha commented, “When endovascular intervention is necessary, PAD lesions are mostly treated through femoral artery access. However, many PAD patients could benefit from faster ambulation time postprocedure that radial artery access offers. In addition, some patients may have comorbidities, such as obesity, that complicate or preclude femoral access.”
Dr. Lodha continued, “The benefits of radial access for percutaneous peripheral vascular interventions are well documented. We believe this study will demonstrate that many of these known benefits, such as low complication rates, high-cost effectiveness, and a short time to ambulation, can be achieved using orbital atherectomy to treat lower limb PAD lesions through radial access.”