Coronary Artery Disease Clinical Trial
Official title:
The Asahi Intecc PTCA Chronic Total Occlusion Study
The primary objective of this trial is to evaluate confirmation of placement of any guidewire
beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at
least one Asahi series of guidewires and/or Corsair microcatheter were used.
Procedure success will be defined as angiographic visualization of any guidewire in a
position either distal or proximal to the occlusion depending on the route of access and the
absence of in-hospital major adverse cardiac events (MACE).
This prospective, multi-center, single-arm, intent-to-treat (ITT) study is designed to assess
the safety and effectiveness of the investigational products for the treatment of CTOs in a
native coronary artery.
The primary objective of this trial is to evaluate confirmation of placement of any guidewire
beyond the CTO in the true vessel lumen in patients in which at least one Asahi series of
guidewires and/or Corsair microcatheter were used.
The population for this study is subjects with signs and/or symptoms considered typical of
ischemic heart disease attributed to a CTO in a native coronary artery, who are suitable for
a percutaneous revascularization.
Procedure success will be defined as angiographic visualization of any guidewire in a
position either distal or proximal to the occlusion depending on the route of access and the
absence of in-hospital major adverse cardiac events (MACE). All subjects are followed through
hospital discharge.
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