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

NCT01435031 | Completed Results

• 1 other identifier: 11-394
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)

  The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.

  1 year

• Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)

  The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.

  1 year

• Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)

  Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on ARC MI (component 2)

  Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

• Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)

  Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on protocol MI (component 2)

  Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

• Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO

  1. Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and; 2. Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and; 3. Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and; 4. Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure

  Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Secondary Outcomes (90)

• Minimum Lumen Diameter (MLD): Pre-procedure

  Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

• Minimum Lumen Diameter (MLD): Post-procedure

  Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

• Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure

  Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

• Percentage of Participants With Change in TIMI Flow Grade: Post-procedure

  Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

• Percentage of Participants With Device Success

  Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

Study Arms (1)

CTO Treatment

OTHER

Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation

Device: CTO Treatment Device

Interventions

CTO Treatment Device DEVICE

Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation

CTO Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 percutaneous coronary intervention (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 (ICF) approved by a local Institutional Review Board/Ethics Committee and to follow the protocol with up to 5-year follow up.
• 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.
• 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
• Occluded segment suitable for placement of coronary stents:
• Segment without severe tortuosity (angulation ≥ 45º)
• Segment not located in an excessively distal location

You may not qualify if:

• Candidates will be excluded from the study if any of the following conditions are present:
• 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
• 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)
• Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel
• Planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure
• 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)
• 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)
• 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.
• 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
• Patients with evidence of ongoing or active clinical instability including the following:
• Sustained systolic blood pressure \< 100 mmHg or cardiogenic shock

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

Related Publications (1)

• 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.

  PMID: 25912400 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Jennifer M Jones-McMeans, PhD (Associate Director Clinical Research)
• Organization: Abbott Vascular

jennifer.jones@av.abbott.com

408-845-1459

Study Officials

• David E. Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 15, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2017
• Last Updated: May 9, 2018
• Results First Posted: November 25, 2014

Record last verified: 2018-02

Locations

US (1)