A clinical trial studying the safety and effectiveness of Cardiovascular Systems’ Diamondback 360 system to treat peripheral arterial disease above the knee has competed its patient enrollment.
The COMPLIANCE 360 trial enrolled 50 patients at nine centers and will measure the primary outcomes of target lesion revascularization or restenosis at six months. Additionally, the St. Paul, Minn.-based company said that the trial will assess 24-month economic data regarding procedural and hospitalization costs of the Diamondback system.
Raymond Dattilo, MD, of the Kansas Heart and Vascular Center and Cardiology Consultants in Topeka, is the trial’s principal investigator.
The COMPLIANCE trial is part of the company’s 360 clinical series, including the CALCIUM 360 trial that studies the effects of the Diamondback 360 system.