Leadership in Clinical Rigor

CSI’s 360° Clinical Study Series

CSI is committed to accumulating evidence-based clinical and economic data that improves the lives of PAD patients and their families. Our responsible, rigorous and pioneering approach to clinical studies is being demonstrated in the ongoing 360° Clinical Series, the first-of-their-kind prospective, randomized, multi-center studies. This series is quickly adding to CSI’s foundation of evidence-based data, including OASIS and OASIS LT, to advance the standards of care in treating patients with PAD.

 

 

OASIS1 

Conducted to Evaluate the Safety and Efficacy of the Diamondback 360® PAD System in Patients with PAD

  • Prospective, multi-center
  • Fulfilled FDA requirements for product clearance in 2007

 

Conclusions

  • 124 patients followed for 6 months post-procedure
  • No major dissections
  • Extremely low embolization rate of 0.8%
  • Unprecedented bailout stent rate of only 2.5%

At 180 days:

  • No major or unplanned minor amputations
  • Improvements in Rutherford Class and ABI maintained

 

OASIS Long-Term Follow-Up2 

Two-Year Data Shows Durable Outcomes in Patients Treated with the Diamondback 360° PAD System

  • Retrospective review of two-year outcomes of 64 out of 124 available OASIS patients
  • Subset of patients from 12 of 17 enrolling medical centers
  • Representative of 103 out of 201 lesions
  • Patient and lesion characteristics similar to those in the entire OASIS population

 

Conclusions

OASIS LT patients followed 24+ months (median 29)

  • Durable TLR of 13.6% at 24 months
  • 100% limb salvage rate maintained
  • No additional amputations
  • Significantly improved ABI
    • 0.61 (at baseline) to 0.90 at last follow-up
    • +0.29 from baseline (p<0.0001)
       

 

 

The COMPLIANCE 360° and CALCIUM 360° studies further elevate industry standards for clinical rigor by confidently comparing a current standard of care – balloon therapy – to a primary treatment of plaque modification with the Diamondback 360° PAD System.

 

COMPLIANCE 360°

  •  Prospective, randomized, multi-center
  • Evaluates the clinical benefit of alteration in lesion compliance by comparing the Diamondback 360° to high-pressure balloon angioplasty
  • Calcified femoral-popliteal vessels
  • 50 patients (25 each arm)
  • First enrollment: June 2009

 

 

CALCIUM 360°

  • Prospective, randomized, multi-center
  • Comparing effectiveness of Diamondback 360° to POBA
  • Calcified popliteal, tibial and peroneal lesions
  • First enrollment: November 2009

 

 

1. Safian R. OASIS results. Catheterization and Cardiovascular Interventions. 2009; 73:406-412.

2. CSI data on file 2009.

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