“We have now 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,” said David L. Martin, president and CEO of Cardiovascular Systems. “Through these studies, we are also collecting 24-month economic data for informed clinical decisions.” The COMPLIANCE 360° trial is 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. The study has enrolled 50 patients at nine investigational sites and will follow patients for 12 months. Interventional cardiologists and vascular surgeons are participating in the study. The primary endpoint is six-month restenosis (measured by arterial Duplex ultrasound with PSVR >2.5), or TLR (including the need for bailout stenting at procedure time). 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.
“Treatment with stents has significant shortcomings in the above-the-knee region, and we need more effective, durable options,” said Dr. Dattilo. “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.” Dr. Dattilo described the COMPLIANCE 360° trial in an article in the March 2010 issue of Endovascular Today.
“We have now 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,” said David L. Martin, president and CEO of Cardiovascular Systems. “Through these studies, we are also collecting 24-month economic data for informed clinical decisions.” The COMPLIANCE 360° trial is 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. The study has enrolled 50 patients at nine investigational sites and will follow patients for 12 months. Interventional cardiologists and vascular surgeons are participating in the study. The primary endpoint is six-month restenosis (measured by arterial Duplex ultrasound with PSVR >2.5), or TLR (including the need for bailout stenting at procedure time). 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.
“Treatment with stents has significant shortcomings in the above-the-knee region, and we need more effective, durable options,” said Dr. Dattilo. “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.” Dr. Dattilo described the COMPLIANCE 360° trial in an article in the March 2010 issue of Endovascular Today.