Clinical trial NCT01435031: EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
Official title: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease (CAD)
Chronic Total Occlusion (CTO)
Keywords: Angioplasty
Chronic Total Occlusion (CTO)
Chronic total coronary occlusions
Coronary Artery Disease (CAD)
Coronary artery stenosis
Total coronary occlusion
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-09-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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 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.

Primary outcomes:
measure: Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)
timeFrame: 1 year
measure: Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)
timeFrame: 1 year
measure: Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Secondary outcomes:
measure: Minimum Lumen Diameter (MLD): Pre-procedure
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Minimum Lumen Diameter (MLD): Post-procedure
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Change in TIMI Flow Grade: Post-procedure
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Device Success
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedure Success
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Antegrade Crossing
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Knuckle Wire
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Reverse CART
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Kissing Wire Technique
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Sub Intimal Technique
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Procedural Success With Multiple Crossing Techniques
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Resource Utilization: Procedural Time
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Resource Utilization: Fluoroscopic Time
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Resource Utilization: Contrast Volume
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Percentage of Participants With Clinically Significant Perforation
timeFrame: Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 30 days
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 6 months
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 1 year
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 2 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 3 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE)
timeFrame: 4 years
measure: Number of Participants Experiencing Death
timeFrame: 30 days
measure: Number of Participants Experiencing Death
timeFrame: 6 months
measure: Number of Participants Experiencing Death
timeFrame: 1 year
measure: Number of Participants Experiencing Death
timeFrame: 2 years
measure: Number of Participants Experiencing Death
timeFrame: 3 years
measure: Number of Participants Experiencing Death
timeFrame: 4 years
measure: Number of Participants Experiencing Cardiac Death
timeFrame: 30 days
measure: Number of Participants Experiencing Cardiac Death
timeFrame: 6 months
measure: Number of Participants Experiencing Cardiac Death
timeFrame: 1 year
measure: Number of Participants Experiencing Cardiac Death
timeFrame: 2 years
measure: Number of Participants Experiencing Cardiac Death
timeFrame: 3 years
measure: Number of Participants Experiencing Cardiac Death
timeFrame: 4 years
measure: Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
timeFrame: 30 days
measure: Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
timeFrame: 6 months
measure: Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
timeFrame: 1 year
measure: Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
timeFrame: 2 years
measure: Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
timeFrame: 3 years
measure: Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
timeFrame: 4 years
measure: Number of Participants With Target Vessel-related MI
timeFrame: 30 days
measure: Number of Participants With Target Vessel-related MI
timeFrame: 6 months
measure: Number of Participants With Target Vessel-related MI
timeFrame: 1 year
measure: Number of Participants With Target Vessel-related MI
timeFrame: 2 years
measure: Number of Participants With Target Vessel-related MI
timeFrame: 3 years
measure: Number of Participants With Target Vessel-related MI
timeFrame: 4 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 30 days
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 6 months
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 2 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 4 years
measure: Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
timeFrame: 30 days
measure: Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
timeFrame: 6 months
measure: Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)
timeFrame: 1 year
measure: Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
timeFrame: 2 years
measure: Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
timeFrame: 3 years
measure: Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
timeFrame: 4 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 30 days
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 6 months
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 1 year
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 2 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 3 years
measure: Number of Participants With All Target Vessel Revascularization (TVR)
timeFrame: 4 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 30 days
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 6 months
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 1 year
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 2 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 3 years
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 4 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 30 days
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 6 months
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 1 year
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 2 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 3 years
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 4 years
measure: Number of Participants With Stent Thrombosis
timeFrame: Acute (0-24 hours)
measure: Number of Participants With Stent Thrombosis
timeFrame: Subacute (>24 hours to 30 days)
measure: Number of Participants With Stent Thrombosis
timeFrame: Late (>30 days to 1 year)
measure: Number of Participants With Stent Thrombosis
timeFrame: 1 year
measure: Number of Participants With Stent Thrombosis
timeFrame: 2 years
measure: Number of Participants With Stent Thrombosis
timeFrame: 3 years
measure: Number of Participants With Stent Thrombosis
timeFrame: 4 years
measure: Number of Participants With Occurrence of Stent Fracture at Target Lesion
timeFrame: 1 year
measure: Number of Participants With Occurrence of Stent Fracture at Target Lesion
timeFrame: 2 years
measure: Number of Participants With Occurrence of Stent Fracture at Target Lesion
timeFrame: 3 years
measure: Number of Participants With Occurrence of Stent Fracture at Target Lesion
timeFrame: 4 years
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: Piedmont Heart Institute
name: David E. Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kandzari DE, Kini AS, Karmpaliotis D, Moses JW, Tummala PE, Grantham JA, Orr C, Lombardi W, Nicholson WJ, Lembo NJ, Popma JJ, Wang J, Larracas C, Rutledge DR. Safety and Effectiveness of Everolimus-Eluting Stents in Chronic Total Coronary Occlusion Revascularization: Results From the EXPERT CTO Multicenter Trial (Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions). JACC Cardiovasc Interv. 2015 May;8(6):761-769. doi: 10.1016/j.jcin.2014.12.238. Epub 2015 Apr 22.