NOVAFIM - Escorts Heart Institute Angiographic Study

Agarwal P 1 , Bhandari S, Subramanyam K, Kapoor R, Kumar P, Chugh S, Shahi M, Singh B, Mathur A, Kasliwal R, Kler Ts, Trehan N.
Escorts Delhi .Indian Heart Journal 2006

Number of patients enrolled – 120

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Inclusion Criteria

• De-Novo Lesions
• Multi-vessel disease
• Vessel Diameter 2.5-3.5mm
• Target Lesion <30mm
• Thrombotic lesions occupying

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Exclusion Criteria

• Ongoing AMI
• Post CABG patients
• Unprotected left main artery
• Involving side branch of –>2mm diameter

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Results

• In Hospital MACE
  
  

  

• 30 Days MACE
  
  

  

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NovaFim - 6 Months QCA Results

• Total patients enrolled – 120
• Total stents deployed – 168
• Avgerage stents / patients – 1.40
• No. of angiographic follow ups done – 97(81%)

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Primary Endpoint

• 100% successful deployment
• In-Hospital MACE - 1 patient CABG & MI(wire induced)
• 30 day MACE - 1 Death

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Secondary End points

TLR 1.66%, 1 Death, 1 MI (occurred within 30 days)

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Conclusion

Pronova stent is efficious and safe with low MACE rates.