EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective percutaneous revascularization of native chronic total coronary occlusions

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 percutaneous coronary intervention (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 (ICF) approved by a local Institutional Review Board/Ethics Committee and to follow the protocol with up to 5-year follow up.
6. Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before enrollment and effective birth control must be used up to 1 year following the index procedure.

Angiographic Inclusion Criteria

1. A maximum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. A "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram:

   • High-grade native coronary stenosis
   • TIMI 0 or 1 antegrade flow

2. Occluded segment suitable for placement of coronary stents:

   • Segment without severe tortuosity (angulation ≥ 45º)
   • Segment not located in an excessively distal location

General Exclusion Criteria

Candidates will be excluded from the study if any of the following conditions are present:

1. Patients with any history of allergy to iodinated contrast that cannot be effectively managed medically, or any known allergy to clopidogrel bisulfate (Plavix®), aspirin, heparin, stainless steel, or everolimus

2. Evidence of acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q-wave or non-Q-wave MI having creatine kinase (CK) enzymes 2 × the upper limit of normal (ULN) with the presence of a creatine kinase myocardial-band isoenzyme (CK-MB) above the Institution's ULN, or troponin (I or T) above the Institution's ULN)

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

4. Planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure

5. Planned interventional treatment of either the target or any non-target vessel within 6 months post-procedure with any alternative drug eluting stent (DES) (e.g., CYPHER Sirolimus-Eluting stent, TAXUS Paclitaxel-Eluting stent or Endeavor Zotarolimus-Eluting Endeavor stent)

6. 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)

7. Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement (including, but not limited to directional or rotational coronary atherectomy, excimer laser, thrombectomy, etc.). Note: Use of alternative technologies to conventional guide wires that are approved by the United States Food and Drug Administration for CTO revascularization (e.g., Asahi Tornus and Corsair catheters, IntraLuminal Therapeutics Safe Cross guide wire, Flowcardia CROSSER system) is permitted and will be collected in the case report form.

8. Patients with history of clinically significant abnormal laboratory findings including:

   • Neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks, or
   • Thrombocytopenia (<100,000 platelets/mm3), or
   • Aspartate Transaminase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase, or bilirubin > 1.5 × ULN, or
   • Serum creatinine > 1.5 mg/dL

9. Patients 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

10. Target lesion involves a bifurcation including a diseased side branch ≥2.25 mm in diameter that would require treatment

11. Target vessel with a patent bypass graft from prior coronary bypass surgery

12. Proximal coronary stenting of target lesion

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

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

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

16. Patients 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.

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

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

19. 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; or requires coronary angiography, intravascular ultrasound (IVUS), or other coronary artery imaging procedures

Angiographic Exclusion Criteria

Candidates will be excluded from study if any of the following conditions are met:

1. Occlusion involves segment within previous stent

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

3. 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.

4. The target vessel has other lesions proximal to the total occlusion identified with greater than 40% diameter stenosis based on visual estimate or on-line quantitative coronary angiography (QCA). However, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (ie, tandem lesions) are acceptable.

Exclusion Criteria (Non-target Lesion):

1. The lesion is located in a native vessel distal to anastomosis with a graft.

2. The vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.

3. The vessel has evidence of thrombus.

4. The vessel is excessively tortuous.

5. The lesion has any of the following characteristics:

   • Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), or right coronary artery (RCA).
   • Involves a side branch > 2.0 mm in diameter.
   • Is at or distal to a > 45º bend in the vessel.
   • Is moderately to severely calcified.
   • TIMI flow 0 or 1.