Coronary Artery Chronic Total Occlusion, Coronary Artery Disease
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICECrossing of Coronary Artery CTO
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
Sponsors
Medpace, Inc.
Asahi Intecc USA Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria: 1. Subject is ≥ 18 years of age at the time of consent 2. Subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization 3. Subject is eligible and consents to undergo PCI procedure 4. Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG) 5. Subject is willing and able to sign an Informed Consent Form approved by a local Institutional Review Board 6. Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before the study procedure Angiographic Inclusion Criteria: 7. A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. Non-study lesions will be treated first. A chronic total occlusion is any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (TIMI 0) and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram. An attempt to cross the target lesion with at least one Asahi guidewire or a Corsair microcatheter must be made.
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | Through hospital discharge, typically 24 hours post procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of In-hospital MACE | Up to hospital discharge | Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI. |
| Frequency of Perforation | During Procedure | Frequency of perforation during the procedure. |
| Frequency of Dissection | During procedure | Frequency of dissection reported during the procedure |
| Frequency of Successful Recanalization | During Procedure | Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area. |
| Mean Contrast Volume | During Procedure | Volume of contrast administered during procedure |
| Mean Absorbed Radiation Dose in mGy | During Procedure | Absorbed radiation dose in mGy during procedure |
| Procedural Success (Evaluated According to Crossing Technique) | Through hospital discharge | The percentage of subjects with procedure success according to crossing technique |
| Mean Procedural Time | During Procedure | 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.) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crossing of Coronary Artery CTO This is a single arm intent to treat study. A subject is considered enrolled when the subject has given informed consent and meets all inclusion and exclusion criteria, including angiographic inclusion and exclusion criteria, which includes an attempt to cross the target lesion with an investigational device (ASAHI PTCA Guidewire or ASAHI Corsair Microcatheter). Clinical evaluation up to hospital discharge is conducted on all enrolled subjects. The purpose of the clinical follow-up is to determine if the subject has experienced or is experiencing any adverse events. | 163 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
Baseline characteristics
| Characteristic | Crossing of Coronary Artery CTO |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 142 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / 163 |
| serious Total, serious adverse events | 37 / 163 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crossing of Coronary Artery CTO | Procedure Success | 119 Participants |
Secondary
Frequency of Dissection
Frequency of dissection reported during the procedure
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crossing of Coronary Artery CTO | Frequency of Dissection | 7 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crossing of Coronary Artery CTO | Frequency of In-hospital MACE | 31 Participants |
Secondary
Frequency of Perforation
Frequency of perforation during the procedure.
Time frame: During Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crossing of Coronary Artery CTO | Frequency of Perforation | 21 Participants |
Secondary
Frequency of Successful Recanalization
Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.
Time frame: During Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crossing of Coronary Artery CTO | Frequency of Successful Recanalization | 145 Participants |
Secondary
Mean Absorbed Radiation Dose in mGy
Absorbed radiation dose in mGy during procedure
Time frame: During Procedure
Population: Data recorded for 161 of 163 subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crossing of Coronary Artery CTO | Mean Absorbed Radiation Dose in mGy | 2612.7 milligray (mGy) | Standard Deviation 1881.3 |
Secondary
Mean Contrast Volume
Volume of contrast administered during procedure
Time frame: During Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crossing of Coronary Artery CTO | Mean Contrast Volume | 287.3 milliliters | Standard Deviation 141.7 |
Secondary
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
Population: Data collected for 162 of 163 subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crossing of Coronary Artery CTO | Mean Procedural Time | 118.5 minutes | Standard Deviation 68.4 |
Secondary
Procedural Success (Evaluated According to Crossing Technique)
The percentage of subjects with procedure success according to crossing technique
Time frame: Through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crossing of Coronary Artery CTO | Procedural Success (Evaluated According to Crossing Technique) | 67 Participants |
| Retrograde Only | Procedural Success (Evaluated According to Crossing Technique) | 6 Participants |
| Antegrade and Retrograde | Procedural Success (Evaluated According to Crossing Technique) | 46 Participants |