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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
163
Standard angiographic procedures will be followed for this 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 MACE. Other Name: ASAHI Corsair Microcatheter, ASAHI PTCA Guide Wires
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Procedure Success
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 MACE.
Time frame: Through hospital discharge, typically 24 hours post procedure
Frequency of Successful Recanalization
Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.
Time frame: During Procedure
Frequency of In-hospital MACE
Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI.
Time frame: Up to hospital discharge
Frequency of Perforation
Frequency of perforation during the procedure.
Time frame: During Procedure
Frequency of Dissection
Frequency of dissection reported during the procedure
Time frame: During procedure
Mean Procedural Time
The length of the procedure (The first successful insertion of the guide catheter at an arteriotomy site is considered the start of the procedure. A procedure is considered complete once the guide catheter is removed from the arteriotomy site.)
Time frame: During Procedure
Mean Contrast Volume
Volume of contrast administered during procedure
Time frame: During Procedure
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Advocate Health and Hospitals Corp.
Oakbrook Terrace, Illinois, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
PeaceHealth Sacred Heart Medical Center
Springfield, Oregon, United States
York Hospital
York, Pennsylvania, United States
...and 2 more locations
Mean Absorbed Radiation Dose in mGy
Absorbed radiation dose in mGy during procedure
Time frame: During Procedure
Procedural Success (Evaluated According to Crossing Technique)
The percentage of subjects with procedure success according to crossing technique
Time frame: Through hospital discharge