Trial Outcomes & Findings for The Asahi Intecc PTCA Chronic Total Occlusion Study (NCT NCT02379923)

NCT ID: NCT02379923

Last Updated: 2018-07-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 163 participants
• Primary outcome timeframe: Through hospital discharge, typically 24 hours post procedure
• Results posted on: 2018-07-18

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	163
Overall Study COMPLETED	158
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure

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.

Overall Study Death

5

Baseline Characteristics

The Asahi Intecc PTCA Chronic Total Occlusion Study

Baseline characteristics by cohort

Measure	Crossing of Coronary Artery CTO n=163 Participants 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.
Age, Continuous	65.5 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	142 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Crossing of Coronary Artery CTO n=163 Participants 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.	Retrograde Only Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde Subjects were both antegrade and retrograde techniques were used
Procedure Success	119 Participants	—	—

SECONDARY outcome

Timeframe: During Procedure

Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.

Outcome measures

Measure	Crossing of Coronary Artery CTO n=163 Participants 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.	Retrograde Only Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde Subjects were both antegrade and retrograde techniques were used
Frequency of Successful Recanalization	145 Participants	—	—

SECONDARY outcome

Timeframe: Up to hospital discharge

Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI.

Outcome measures

Measure	Crossing of Coronary Artery CTO n=163 Participants 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.	Retrograde Only Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde Subjects were both antegrade and retrograde techniques were used
Frequency of In-hospital MACE	31 Participants	—	—

SECONDARY outcome

Timeframe: During Procedure

Frequency of perforation during the procedure.

Outcome measures

Measure	Crossing of Coronary Artery CTO n=163 Participants 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.	Retrograde Only Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde Subjects were both antegrade and retrograde techniques were used
Frequency of Perforation	21 Participants	—	—

SECONDARY outcome

Timeframe: During procedure

Frequency of dissection reported during the procedure

Outcome measures

Measure	Crossing of Coronary Artery CTO n=163 Participants 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.	Retrograde Only Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde Subjects were both antegrade and retrograde techniques were used
Frequency of Dissection	7 Participants	—	—

SECONDARY outcome

Timeframe: During Procedure

Population: Data collected for 162 of 163 subjects

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.)

Outcome measures

Measure	Crossing of Coronary Artery CTO n=162 Participants 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.	Retrograde Only Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde Subjects were both antegrade and retrograde techniques were used
Mean Procedural Time	118.5 minutes Standard Deviation 68.4	—	—

SECONDARY outcome

Timeframe: During Procedure

Volume of contrast administered during procedure

Outcome measures

Measure	Crossing of Coronary Artery CTO n=163 Participants 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.	Retrograde Only Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde Subjects were both antegrade and retrograde techniques were used
Mean Contrast Volume	287.3 milliliters Standard Deviation 141.7	—	—

SECONDARY outcome

Timeframe: During Procedure

Population: Data recorded for 161 of 163 subjects

Absorbed radiation dose in mGy during procedure

Outcome measures

Measure	Crossing of Coronary Artery CTO n=161 Participants 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.	Retrograde Only Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde Subjects were both antegrade and retrograde techniques were used
Mean Absorbed Radiation Dose in mGy	2612.7 milligray (mGy) Standard Deviation 1881.3	—	—

SECONDARY outcome

Timeframe: Through hospital discharge

The percentage of subjects with procedure success according to crossing technique

Outcome measures

Measure	Crossing of Coronary Artery CTO n=74 Participants 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.	Retrograde Only n=9 Participants Subjects where only a retrograde crossing technique was used	Antegrade and Retrograde n=80 Participants Subjects were both antegrade and retrograde techniques were used
Procedural Success (Evaluated According to Crossing Technique)	67 Participants	6 Participants	46 Participants

Adverse Events

Crossing of Coronary Artery CTO

Serious events: 37 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Crossing of Coronary Artery CTO n=163 participants at risk 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. Crossing 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.
Cardiac disorders Angina pectoris	0.61% 1/163 • Number of events 1
Cardiac disorders Arrhythmia	1.2% 2/163 • Number of events 2
Cardiac disorders Atrial fibrillation	0.61% 1/163 • Number of events 1
Cardiac disorders Cardiac arrest	0.61% 1/163 • Number of events 1
Cardiac disorders Cardiac failure acute	0.61% 1/163 • Number of events 1
Cardiac disorders Cardiac tamponade	0.61% 1/163 • Number of events 1
Cardiac disorders Cardiogenic shock	0.61% 1/163 • Number of events 1
Cardiac disorders Coronary artery dissection	1.2% 2/163 • Number of events 2
Cardiac disorders Coronary artery perforation	11.7% 19/163 • Number of events 19
Cardiac disorders Myocardial infarction	3.1% 5/163 • Number of events 5
Cardiac disorders Pericardial effusion	6.1% 10/163 • Number of events 10
Cardiac disorders Pericarditis	0.61% 1/163 • Number of events 1
Cardiac disorders Pulseless electrical activity	0.61% 1/163 • Number of events 1
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.61% 1/163 • Number of events 1
Blood and lymphatic system disorders Retroperitoneal haemorrhage	0.61% 1/163 • Number of events 1
General disorders Catheter site haematoma	0.61% 1/163 • Number of events 1
General disorders Catheter site haemorrhage	2.5% 4/163 • Number of events 4
General disorders Multi-organ failure	0.61% 1/163 • Number of events 1
General disorders Vascular stent thrombosis	0.61% 1/163 • Number of events 1
Infections and infestations Urinary tract infection	0.61% 1/163 • Number of events 1
Injury, poisoning and procedural complications Post procedural hematoma	0.61% 1/163 • Number of events 1
Injury, poisoning and procedural complications Vascular procedure complication	0.61% 1/163 • Number of events 1
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.61% 1/163 • Number of events 1
Investigations Haemoglobin decreased	1.2% 2/163 • Number of events 2
Metabolism and nutrition disorders Lactic acidosis	0.61% 1/163 • Number of events 1
Musculoskeletal and connective tissue disorders Groin pain	0.61% 1/163 • Number of events 1
Nervous system disorders Brain injury	0.61% 1/163 • Number of events 1
Nervous system disorders Presyncope	0.61% 1/163 • Number of events 1
Renal and urinary disorders Acute kidney injury	1.8% 3/163 • Number of events 3
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.61% 1/163 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.61% 1/163 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.61% 1/163 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.61% 1/163 • Number of events 1
Vascular disorders Hypotension	3.7% 6/163 • Number of events 6
Vascular disorders Orthostatic hypotension	1.2% 2/163 • Number of events 2
Vascular disorders Peripheral ischaemia	0.61% 1/163 • Number of events 1

Other adverse events

Measure	Crossing of Coronary Artery CTO n=163 participants at risk 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. Crossing 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.
Cardiac disorders Myocardial infarction	13.5% 22/163 • Number of events 22
General disorders Catheter site haematoma	7.4% 12/163 • Number of events 12

Additional Information

Robert Ricker

Asahi Intecc USA, Inc.

Phone: 408.429.3749

Email: robertr@asahi-intecc.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI may publish the results of its data 1 year after completion of the Study. Sponsor can review results prior to public release and embargo communications regarding results for a period ≤60 days from the time submitted to the sponsor for review. Sponsor may request in writing (a) deletion of any Confidential Information, (b) reasonable changes requested by Sponsor, or (c) delay of proposed submission for another period ≤90 days in order to protect the potential patentability of any technology.
• Publication restrictions are in place

Restriction type: OTHER