The Asahi Intecc PTCA Chronic Total Occlusion Study

Completed · Not applicable

Conditions studied: Coronary Artery Disease, Coronary Artery Chronic Total Occlusion

In brief

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).

Key facts

Study ID

NCT02379923

Run by

Asahi Intecc USA Inc

People needed

163

Starts

2015-06-01

Expected to finish

2016-01-01

Last updated by the study team

2018-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Banner - University Medical Center Phoenix — Phoenix, Arizona, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• 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
• Dallas VA Medical Center — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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