Cardiovascular Systems (CSI) has completed patient enrollment in its prospective, randomized CALCIUM 360° clinical trial, part of the company’s 360° clinical series.
The St. Paul, Minn.-based company said its CALCIUM 360° feasibility study is evaluating the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI’s Diamondback 360 System, a minimally invasive catheter-based orbital atherectomy device for treating PAD anywhere in the leg. Nicolas Shammas, MD, an interventional cardiologist at Trinity Medical Center in Bettendorf, Iowa, is the study’s principal investigator.
The CALCIUM 360° trial is comparing the effectiveness of the Diamondback 360° atherectomy device to balloon angioplasty in treating atherosclerosis in the smaller vessels behind and below the knee (popliteal, tibial and peroneal), CSI said. The study enrolled 50 patients at eight investigational sites and is following patients for 12 months. Interventional cardiologists and vascular surgeons are participating in the study.
The primary endpoint is 30 percent or less residual stenosis, with no major dissection. In addition to collecting clinical outcomes, the CALCIUM 360° study will gauge the economic utility of both the Diamondback 360° and angioplasty procedures and subsequent hospitalizations.