The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Acute Success: Device success (lesion based analysis)
Timeframe: From the start of index procedure to end of index procedure
Acute Success: Procedural success (patient based analysis)
Timeframe: From the start of index procedure to end of index procedure
Death (Cardiovascular, Non-Cardiovascular)
Timeframe: 1 year
Death (Cardiovascular, Non-Cardiovascular)
Timeframe: 3 year
Myocardial Infarction (MI)
Timeframe: 1 year
MI
Timeframe: 3 year
Target Lesion Revascularization (TLR)
Timeframe: 1 year
TLR
Timeframe: 3 year
TLR
Timeframe: 1 year
TLR
Timeframe: 3 year
Target Vessel Revascularization (TVR)
Timeframe: 1 year
TVR
Timeframe: 3 year
TVR
Timeframe: 1 year
TVR
Timeframe: 3 year
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
Timeframe: 1 year
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
Timeframe: 3 year
Cardiac Death/All MI/ID-TLR (MACE)
Timeframe: 1 year
Cardiac Death/All MI/ID-TLR (MACE)
Timeframe: 3 year
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
Timeframe: 1 year
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
Timeframe: 3 year
Scaffold/Stent Thrombosis
Timeframe: 1 year
Scaffold/Stent Thrombosis
Timeframe: 1 year
Scaffold/Stent Thrombosis
Timeframe: 3 year
Scaffold/Stent Thrombosis
Timeframe: 3 year