The Asahi Intecc PTCA Chronic Total Occlusion Study

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.

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 Exclusion Criteria:

1. Subjects with any history of allergy to iodinated contrast that cannot be
effectively managed medically

2. Evidence of acute Myocardial Infarction (MI) within 72 hours of the intended
treatment defined as cardiac enzymes greater than Upper Limit of Normal (ULN).

3. Previous coronary interventional procedure of any kind within the 30 days prior
to the procedure

4. 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.)

5. Target lesion requires treatment with a device after successful crossing other
than PTCA prior to stent placement

6. 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

7. 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

8. History of stroke or transient ischemic attack within the prior 6 months

9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6
months

10. History of bleeding diathesis or coagulopathy or refusal of blood transfusions

11. 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

12. Known previous medical condition yielding expected survival less than 1 year

13. Subjects who are unable or unwilling to comply with the protocol or not expected
to complete the study period, including its follow-up requirements

14. 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:

15. Occlusion involves segment within previous stent

16. Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)

17. 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

18. 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.