Cardiovascular Systems (CSI) has completed patient enrollment in its prospective, randomized Calcium 360° clinical trial, part of the company’s 360° clinical Series.
The Calcium 360° feasibility study is designed to evaluate the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI’s Diamondback 360 System, a minimally invasive catheter for treating PAD anywhere in the leg.
The trial compares the effectiveness of the Diamondback 360° to balloon angioplasty in treating atherosclerosis in the smaller vessels behind and below the knee (popliteal, tibial and peroneal).
CSI said that the study enrolled 50 patients at eight investigational sites and is following patients for 12 months. The primary endpoint is 30% or less residual stenosis, or plaque remaining, 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.
Calcium 360° is part of CSI’s 360° Clinical Series to demonstrate successful acute outcomes and durable long-term results with the Diamondback 360° System. The Compliance 360° feasibility study, currently under way, is another study in the series that is prospectively evaluating 50 patients treated with either the Diamondback 360° or angioplasty in above-the-knee arteries.
CSI said that the studies complement the already completed Oasis and Oasis Long Term studies that demonstrated the safety, effectiveness and durability of the Diamondback 360° device in treating peripheral vascular disease.
David Martin, president and CEO of CSI, said: “Reaching full enrollment is a significant step in the Calcium 360° trial, one of several studies completed or in progress, that reflect our commitment to providing clinically useful data to patients, their families and their physicians. There is a strong need for safer, more effective and durable treatment options for treating hardened plaque behind and below the knee.”
Jihad Mustapha, an interventional cardiologist at Metro Health Hospital, Grand Rapids, Michigan, who enrolled the most patients in this trial, said: “As the first randomized study in this field, Calcium 360° will provide useful, clinically significant data on the treatment of below-the-knee lesions. Patients with multiple below-the-knee occlusions have traditionally had little hope of salvaging a limb. I have used the Diamondback 360° to modify plaque and restore blood flow in many patients who had been scheduled for amputation.”