Leading the Way in Evidence-Based Medicine

Creating a new standard of care for patients with PAD starts with obtaining quality clinical and economic data. CSI’s 360° Clinical Series highlights our commitment to obtaining clinically relevant data that supports physician treatment decisions and optimal patient outcomes. To date, we have studied more than 2,300 patients with more than 3,500 lesions, and several clinical studies are still underway. This armada of evidence provides physicians with consistent, reproducible data on the safety and efficacy of the Orbital PAD System. Our ongoing commitment to clinical rigor includes data collection on the following:

• Device safety and efficacy, long-term durability, and hospital readmissions
• Economics of the procedure and related follow-up care
• Post-approval physician experiences
• Head-to-head comparisons against alternative treatments

CSI’s clinical trial portfolio contains:

Peripheral Studies

Level I: Randomized Trials

• COMPLIANCE 360°
• CALCIUM 360°

Level II: Multi-Center, Single-Arm Trials

• OASIS
• OASIS Long Term
• CONFIRM Diamondback
• CONFIRM Predator
• CLEAR 360°
• PAD II

Level III: MD-Initiated Studies

• Limb Salvage - Dr. J.A. Mustapha
• Diamondback 360° vs. PTA in Intrapopliteal - Dr. Rago Patlola
• Predator 360° - Dr. Prakash Makam

Coronary Studies

Level II: Multi-Center, Single-Arm Trials

• ORBIT I
• ORBIT II