Cardiovascular Systems (CSI) has completed patient enrollment in its Compliance 360° clinical trial, part of the company’s 360° Clinical Series. The trial has been comparing the benefits of removing plaque and improving vessel compliance above the knee with the Diamondback 360° followed by low-pressure balloon therapy versus treatment with high-pressure balloon inflation alone.
Compliance 360° is a prospective, randomised feasibility study to evaluate the treatment of peripheral arterial disease (PAD) above the knee using CSI’s Diamondback 360 System, a minimally invasive catheter for treating PAD anywhere in the leg.
The study has enrolled 50 patients at nine investigational sites and will follow patients for 12 months. In addition to collecting clinical outcomes, the Compliance 360° study will gauge the economic utility of both the Diamondback 360° and angioplasty procedures by assessing initial procedural costs as well as subsequent hospitalizations.
Cardiovascular Systems said that the Compliance 360° is part of CSI’s 360° Clinical Series to demonstrate successful acute outcomes and durable long-term results with the Diamondback 360°. Reportedly, in April 2010, CSI completed patient enrollment in its Calcium 360°, another prospective, randomized feasibility study in the series evaluating 50 patients treated with either the Diamondback 360° or angioplasty in arteries behind or below the knee.
The studies build upon 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 Cardiovascular Systems, said: “We have completed enrollment in both the Compliance 360° and Calcium 360° clinical trials the first-of-their-kind, complementary initiatives that will provide physicians scientific data to confirm the value of the Diamondback 360° in achieving optimal patient outcomes. Through these studies, we are also collecting 24-month economic data for informed clinical decisions.”
Dr Raymond Dattilo, director of peripheral vascular intervention at the Kansas Heart and Vascular Center and principal investigator of the study, said: “Treatment with stents has significant shortcomings in the above-the-knee region, and we need more effective, durable options. The Diamondback 360° has the ability to remove hard, calcified plaque and better achieve more uniform, circumferential lesion Compliance for patients with above-the-knee PAD.
“The Diamondback 360° facilitates treatment of larger vessels by modifying plaque first, which typically allows for lower pressure adjunctive balloon therapy. Clinical data from the Compliance 360° trial will help the medical community better understand the potential benefits of treating PAD patients with this device.”