The Asahi Intecc PTCA Chronic Total Occlusion Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Asahi Intecc PTCA Chronic Total Occlusion Study

Conditions
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Coronary Artery Disease, Coronary Artery Chronic Total Occlusion

Intervention / Treatment
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* Device: Crossing of Coronary Artery CTO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria: Subject is ≥ 18 years of age at the time of consent 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 Subject is eligible and consents to undergo PCI procedure Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG) Subject is willing and able to sign an Informed Consent Form approved by a local Institutional Review Board 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: 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 Exclusion Criteria: Subjects with any history of allergy to iodinated contrast that cannot be effectively managed medically Evidence of acute Myocardial Infarction (MI) within 72 hours of the intended treatment defined as cardiac enzymes greater than Upper Limit of Normal (ULN). Previous coronary interventional procedure of any kind within the 30 days prior to the procedure Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin, etc.) Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement Subjects with known history of clinically significant abnormal laboratory findings including: Neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks Thrombocytopenia (<100,000 platelets/mm3) AST, ALT, alkaline phosphatase, or bilirubin > 1.5 × ULN Serum creatinine > 2.0 mg/dL Subjects with evidence of ongoing or active clinical instability including the following: Sustained systolic blood pressure < 100 mmHg or cardiogenic shock Acute pulmonary edema or severe congestive heart failure Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade Suspected dissecting aortic aneurysm Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease History of stroke or transient ischemic attack within the prior 6 months Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months History of bleeding diathesis or coagulopathy or refusal of blood transfusions Subjects with any other pathology such as cancer, mental illness, etc., which in the opinion of the Investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study Known previous medical condition yielding expected survival less than 1 year Subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; Angiographic Exclusion Criteria: Occlusion involves segment within previous stent Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4) Previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met: It has been at least 9 months since the previous stenting That target lesion is at least 15 mm away from the previously placed stent The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis, based on visual estimate The target vessel has other lesions proximal to the total occlusion identified with greater than 75% diameter stenosis based on visual estimate. However, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (i.e., tandem lesions) are acceptable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crossing of Coronary Artery CTO<br>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 | Device: Crossing of Coronary Artery CTO<br>* 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<br>* Other names: Corsair, Gaia, Asahi Guide Wires;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through hospital discharge, typically 24 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Successful Recanalization | Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area. | During Procedure | 
| Frequency of In-hospital MACE | Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI. | Up to hospital discharge | 
| Frequency of Perforation | Frequency of perforation during the procedure. | During Procedure | 
| Frequency of Dissection | Frequency of dissection reported during the procedure | 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.) | During Procedure | 
| Mean Contrast Volume | Volume of contrast administered during procedure | During Procedure | 
| Mean Absorbed Radiation Dose in mGy | Absorbed radiation dose in mGy during procedure | During Procedure | 
| Procedural Success (Evaluated According to Crossing Technique) | The percentage of subjects with procedure success according to crossing technique | Through hospital discharge |