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ORBIT I & ORBIT II Coronary Trials

ORBIT Clinical Study Series for CAD Patients

Based on multiple studies and improved outcomes with PAD patients, CSI felt confident embarking on clinical studies using orbital atherectomy in patients with coronary arterial disease (CAD). The ORBIT series studies an overlooked and often untreated set of patients whose severely calcified lesions make them challenging candidates for standard treatments.

ORBIT I1

  • Coronary safety and efficacy feasibility study completed in 2008
        –    2 centers in India
  • Prospective, single arm
  • 50 subjects
  • Mild to severely calcified coronary artery disease
  • MACE at 30 days: 6%

 Conclusions:

  • Orbital atherectomy can be safely used in calcified coronary lesions with low complications
    •             –    Conclusions contributed to FDA approval for ORBIT II study in US

 

ORBIT II*

  • Prospective, single-arm, Investigational Device Exemption trial
  • Up to 50 enrolling U.S. centers
  • 429 patients
    • Currently enrolling
  • Primary safety endpoint: 30-day major adverse events
  • Primary effectiveness endpoint: procedural success

To learn more, click HERE.

 

References:
1.    Parikh, et al. JACC. 2009. Vol. 53, No. 10, Suppl A, p. A20.
* The Diamondback 360° Coronary System is under investigation and is currently not commercially available in the US.

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