First in man experience with a drug-eluting stent in de novo coronary artery lesions


  • In BIOFLOW-I, the Orsiro hybrid DES showed excellent Late Lumen Loss (LLL) results in the overall patient population.
  • BIOFLOW-I has a high rate of diabetic patients and complex lesions, atypical for a FIM study.
  • There was no late catch-up in LLL values at 9-month follow-up. This combined with a narrow standard deviation suggests robust study results.

Study Design

  • Prospective, multi-center, non-randomized, first-in-man trial
  • Primary endpoint: In-stent late lumen loss at 9 months by QCA
  • Coordinating clinical investigator: Prof. Martial Hamon, University Hospital of Caen, France
  • Principal investigators: Dr. Rodica Niculescu and Dr. Dan Deleanu
  • Objective: To assess the safety and clinical performance of the Orsiro hybrid drug-eluting stent in patients with single de novo coronary artery lesions
Picture shows study design

Primary endpoint

Cumulative frequency of in-stent Late Lumen Loss at 4 and 9 months

Primary endpoint graph

Secondary endpoint

MACE defined as composite of cardiac death, MI attributed to the target vessel, stent thrombosis and clinically driven target lesion revascularization. Stent thrombosis was defined according to the Academic Research Consortium definitions.

Secondary endpoint graph

Baseline Characteristics



Orsiro Image

Vascular Intervention

Drug-Eluting Stent

Orsiro Image

Vascular Intervention

Clinical Study

Hamon M et al. Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study. EuroIntervention. 2013; 8: 1006-1011.

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