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CLINICAL TRIALS > SUPRALIMUS SERIES I
Supralimus®

SERIES I 

Study Design
   Principal Investigator: Dr. Sameer Dani
   Study Title: A study with the Supralimus® Sirolimus Eluting Stent in the treatment of patients with real world coronary artery
  lesions.
   Study Design: Real world, Non randomized, multi centric study. One hundred patients were enrolled.
   Study Objective: The primary objective of this study is to assess the safety and efficacy of the Supralimus® Sirolimus Eluting Stent in
  real world coronary artery lesions
   Status: Ongoing
*Published in EuroIntervention May 2008
Baseline Patient Characteristics (n=100)
Variable (%)  
Diabetes Mellitus 29%  
Hypertension 57%  
Hyperlipidaemia 38%  
Smoker 22%  
Previous Myocardial Infarction 56%  
Heart failure 7%  
Previous PCI 6%  
 
Lesion Characteristics (n=126)
Variable    
Chronic occlusion 17 (12%)  
In stent restenosis 1 (1%)  
Ostial lesion 8 (5%)  
Bifurcation 5 (3%)  
Major adverse clinical events (n=100)
Variables 1 Month 6 Months 9 Months 24 Months 30 Months
Death (%) 0 1 2 3 3
Non-fatal Myocardial Infarction (%) 0 0 0 0 0
Death or nonfatal MI (%) 0 1 2 3 3
TVR (%) 0 2 4 4 4
Death or nonfatal MI or TVR (%) 0 3 6 7 7
Freedom from MACE (%) 100 97 94 93 93
Quantitative coronary angiographic analysis (n=59)
  Baseline Post-procedure 6 months
Reference vessel diameter, mm      
          In stent 2.66 ± 0.62 2.86 ± 0.45 2.85 ± 0.46
          In segment   2.80 ± 0.47 2.77 ± 0.48
Minimum lumen diameter, mm      
          In stent  0.73 ± 0.61 2.53 ± 0.43 2.44 ± 0.48
          In segment   2.14 ± 0.49 2.11 ± 0.51
Late loss, mm      
          In stent     0.09 ± 0.28
          In segment     0.02 ± 0.37
Diameter stenosis, %      
          In stent  72.4 ± 21.7 11.5 ± 6.6 14.2 ± 9.9
          In segment   24.0 ± 9.3 23.9 ± 12.7
Binary angiographic restenosis, n (%)      
          In stent     0 (0)
          In segment     1 (1.7)
Reference vessel area, mm2      
          In stent  5.85 ± 2.78 7.05 ± 3.41 6.84 ± 2.83
          In segment   6.41 ± 2.54 6.51 ± 2.42
Minimum lumen area, mm2      
          In stent 0.91 ± 1.08 6.24 ± 2.99 5.63 ± 2.67
          In segment    4.28 ± 2.45 4.30 ± 2.24
Area stenosis, %      
          In stent   84.4 ± 15.9 10.1 ± 21.8 18.0 ± 19.8
          In segment   34.0 ± 20.5 34.8 ± 20.7
 
 
 
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