BIOSOLVE-I

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36-month results
 
 Conclusions
  • No definite or probable late or very late Scaffold Thrombosis (ST) was observed with Magmaris precursor devices in clinical trials up to 36 months
  • Excellent long-term outcomes at 3 years with a low Target Lesion Failure (TLF) rate and no cardiac death or ST
 
 
Study design
Prospective, multi-center, first-in-man trial testing DREAMS (Drug-Eluting Absorbable Magnesium Scaffold).
 

Endpoints
Primary endpoint
  • TLF defined as a composite of cardiac death, Target-Vessel Myocardial Infarction (TV MI) and Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 and 12 monthsSecondary
Secondary endpoints (selected)
  • Late Lumen Loss (LLL) at 6 and 12 months
  • ST at 1, 24 and 36 months
  • Cumulative rates of TLF at 1, 24 and 36 months
 
* TLF defined as a composite of cardiac death, TV MI and CD-TLR

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