Chronic Total Occlusion Percutaneous Coronary Intervention Study

Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study

The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.

A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study. The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll up to 150 patients to provide adequate powering for hypothesis testing and an evaluable sample size of at least 135 patients.

The population for this study is participants with signs and/or symptoms considered typical of ischemic heart disease attributed to a de novo CTO in a native coronary artery who are suitable candidates for a percutaneous revascularization.

Study devices include the GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter, and a series of five coronary guidewires (SpectreTM guidewire, R350TM guidewire, RaiderTM guidewire, WarriorTM guidewire, and BanditTM guidewire). All study devices are currently 510(k) cleared for non-CTO indications.

• GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo chronic total occlusions (CTO).
• The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo chronic total occlusions (CTO).
• The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires, to subselectively infuse/deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO). The Teleflex guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).

Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

General inclusion criteria

1. At least 18 years of age at the time of consent

2. Experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) 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. Participant is eligible and consents to undergo PCI procedure

4. Acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG)

5. Willing and able to sign a study Informed Consent Form (ICF) approved by a local or central Institutional Review Board (IRB)

6. Female participants of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception

   Angiographic inclusion criteria

7. A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting the definition of CTO (any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (Thrombolysis in Myocardial Infarction (TIMI) score of 0 or 1) and estimated to be in duration of ≥ 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram)

Exclusion Criteria:

Participants must not meet any of the following exclusion criteria:

General exclusion criteria

1. History of allergy to iodinated contrast that cannot be effectively managed medically

2. Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as creatine kinase-muscle brain subunits (CK-MB) greater than 3 times the upper limit of normal (ULN)

3. Previous coronary interventional procedure of any kind within 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)

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

6. Atherectomy procedure is planned for the target lesion

7. Known history of clinically significant abnormal laboratory findings ≤ 14 days prior to enrollment, including:

   • Neutropenia (<1000 neutrophils/mm^3)
   • Thrombocytopenia (<100,000 platelets/mm^3)
   • Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase, or bilirubin > 1.5 × ULN
   • Serum creatinine >2.0 mg/dL

8. Evidence of current clinical instability including the following:

   • Sustained systolic blood pressure <100 mmHg or cardiogenic shock
   • Acute pulmonary edema or severe congestive heart failure (CHF). Severe CHF is defined as New York Heart Association (NYHA) Class IV
   • 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

9. History of stroke or transient ischemic attack within 6 months prior to procedure

10. Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure

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

12. Other pathology such as cancer, known mental illness, etc., which might, in the opinion of the Investigator, put the patient at risk or confound the results of the study

13. Unable or unwilling to comply with the protocol

14. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound, or other coronary artery imaging procedures

    Angiographic exclusion criteria

15. Occlusion involves segment within previous stent ("in-stent occlusions")

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
    • Target lesion is ≥15 mm away from the previously placed stent
    • Previously stented segment (stent plus 5 mm on either side) has no more than 40 percent diameter stenosis, based on visual estimate

18. Target vessel has other lesions proximal to the total occlusion identified with > 75 percent diameter stenosis based on visual estimate; exception: planned stenting of a lesion proximal to the target lesion that can be covered by a single stent (i.e., tandem lesions) is acceptable