BIOSOLVE-II

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36-month results
 
 Conclusions
  • Target Lesion Failure (TLF) (6.8%) and Target Lesion Revascularization (TLR) (4.3%) rates in BIOSOLVE-II remain low and are comparable to 2nd generation drug-eluting stents out to 36 months
  • There was no definite or probable Scaffold Thrombosis (ST) up to 36-month follow-up
  • The Late Lumen Loss (LLL) between 12-month and 36-month follow-up remained stable and is similar between target and non-target segment
  • The change in LLL can be attributed to the overall progression of the disease rather than very late effects of the Magmaris beyond its resorption time
 
 
Study design
Prospective, multi-center, first-in-man trial.
 

Primary endpoint
  • In-segment LLL at 6 months
 
 
 


Comparative angiographic analysis of LLL in treated and non-treated vessels
Methodology
Analysis of LLL was run on vessel segments that did not receive the study scaffold in order to assess the cause of LLL.
 
 
 
The LLL between 12-month and 36-month follow-up remained stable and is similar between target and non-target segment. The change in LLL can be attributed to the overall progression of the disease rather than very late effects of the DREAMS 2G beyond its resorption time.
 
 

Principal investigator
 
Prof. M. Haude, Lukaskrankenhaus, Neuss, Germany
1. Unwitnessed death 134 days post PCI of distal RCA, no autopsy available; 2. Unwitnessed death 395 days post PCI of the mid RCA, no autopsy available; 3. Patient died of cancer; 4. Patient died of pulmonary infection leading to septic shock; 5. Patient died of intracerebral hemorrhage.

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