Loading clinical trials...

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

COMPLETEDNA

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

NCT01435031•Abbott Medical Devices

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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:
+2 more criteria

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
+37 more criteria

Locations (1)

Abbott Vascular

Santa Clara, California, United States

Key Dates

Start Date

September 1, 2011

Primary Completion Date

February 1, 2014

Completion Date

December 1, 2017

Last Updated

May 9, 2018

Enrollment

250

ACTUAL participants

Conditions

Coronary Artery Disease (CAD)Chronic Total Occlusion (CTO)

Interventions

CTO Treatment Device

DEVICE

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

View study

RECRUITING

Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice

NCT07114393

Coronary Artery DiseaseCoronary Artery Disease (Left Main)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

"Erectile Function After PCI in MI and Non-MI Patients"

Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice

Dedinje FFR/QFR Registry

Coronary Laser in Undilatable or Uncrossable Lesions

Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation Program

Predictors and Long-term Incidence of In-stent Restenosis After Chronic Total Occlusion Percutaneous Coronary Intervention