Cardiovascular Systems (CSI) has reported first patient enrollment in its prospective, randomised Calcium 360° clinical trial, part of the company’s 360° Clinical Series.
The Calcium 360° study will evaluate the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI’s Diamondback 360 PAD System, a minimally invasive catheter for treating PAD anywhere in the leg.
Reportedly, the Calcium 360° trial will compare 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).
The study is expected to enroll 50 patients at five investigational sites and follow patients for 12 months. The primary endpoint is 30% or less residual stenosis, or plaque remaining, with no major dissection.
Calcium 360° is the second study in CSI’s 360° Clinical Series, which is designed to demonstrate successful acute outcomes and durable long-term results with the Diamondback 360° PAD System. The Calcium 360° study complements the Compliance 360° study, initiated in June 2009, another prospective, randomised study of 50 patients to evaluate use of the Diamondback 360° in above-the-knee arteries.
CSI has received FDA 510(k) marketing clearance for the Diamondback 360° as a PAD therapy in August 2007 on the basis of data from the Oasis study, the first-ever prospective study evaluating a plaque removal system, which enrolled 124 patients at 20 sites.
David Martin, president and CEO of CSI, said: “CSI is leading the way in collecting clinical data to advance the standard of care for PAD patients, save limbs and lives, and support evidence-based medicine. Calcium 360° focuses on changing the compliance of hardened plaque below the knee, where more effective, durable treatments are especially needed. Through this and our other evaluations, we are also collecting economic data to demonstrate the cost-effectiveness of the Diamondback 360° procedure- a vital consideration in this cost-conscious healthcare environment.”