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A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon | Clinical Trials | Clareo Health

COMPLETEDNA

A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon

A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (EXPANSE-PTCA)

NCT04985773•Infraredx

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.

Detailed Description

The investigation is a prospective, multi-center, single arm clinical study. The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll and treat 200 subjects, including a minimum of 30 subjects with in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA. After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where additional eligibility criteria will be assessed. An angiogram will be completed to assess for angiographic eligibility. If a non-target lesion is identified, it must be treated successfully prior to target lesion treatment. Once treatment of the target lesion(s) has been attempted, the subject will be considered enrolled in the study. Subjects will be followed through hospital discharge.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years or older.
•2. Willing to provide written informed consent and written HIPAA authorization prior to initiation of study-related procedures.
•3. Agree to not participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.
•4. Clinical evidence of ischemic heart disease, stable/unstable angina, or silent ischemia.
•5. Acceptable candidate for PCI and emergency coronary artery bypass grafting and is planned for possible PTCA and/or stent placement.
•6. De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
•7. A maximum of two lesions, including at least one target lesion, in single or double vessel coronary artery disease.
•1. If two target lesions are defined, then no non-target lesions can be treated.
•2. If a single target lesion is defined, then a single non-target lesion may be treated, but if so, it must be located in a different coronary artery from the target lesion.
•8. Target lesion(s) must have a reference vessel diameter between 2.0 mm and 4.0 mm by visual estimation.
+3 more criteria

Exclusion Criteria

•1. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, a clopidogrel non-responder, or sensitivity to contrast media that cannot be adequately pre-medicated or replaced with a clinically suitable alternative.
•2. Known diagnosis of type I myocardial infarction (resulting from primary reduction of flow from a culprit lesion likely to have a thrombotic component) within 7 days prior to the index procedure.
•3. Known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days prior to index procedure.
•4. Planned target lesion treatment with atherectomy (rotational, orbital or laser), cutting balloon, thrombectomy, lithotripsy or an unapproved device during the index procedure.
•5. Serum creatinine \>2.0 mg/dl within 7 days prior to the index procedure.
•6. Cerebrovascular accident within 6 months prior to the index procedure.
•7. Active peptic ulcer or active gastrointestinal bleeding within 6 months prior to the index procedure.
•8. Left ventricular ejection fraction \<30% based on most recent measurement within a year of the index procedure (if LVEF is not available in the medical records, it may be obtained at the time of the index procedure, prior to enrollment).
•9. Target lesion located within a bypass graft (venous or arterial) or graft anastomosis.
•10. Previous percutaneous intervention, within 9 months before the study procedure, on lesions in a target vessel (including side branches) that are located within 10 mm from the current target lesion(s).
+18 more criteria

Locations (10)

VA Palo Alto Health System

Palo Alto, California, United States

Baptist Health Lexington

Lexington, Kentucky, United States

M Health Fairview

Maplewood, Minnesota, United States

Minneapolis Heart Institute - Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Cardiology Associates Research

Tupelo, Mississippi, United States

Columbia University Medical Center

New York, New York, United States

Cornell University

New York, New York, United States

St Francis Hospital

Roslyn, New York, United States

Ascension Saint Thomas Heart West

Nashville, Tennessee, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

December 17, 2021

Primary Completion Date

December 16, 2022

Completion Date

December 16, 2022

Last Updated

January 12, 2024

Enrollment

200

ACTUAL participants

Conditions

Coronary StenosisCoronary Artery StenosisIn-stent Restenosis

Interventions

Lacrosse NSE ALPHA coronary dilatation catheter

DEVICE

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

NCT06535568

Coronary DiseaseHeart Diseases+23 more

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RECRUITINGNA

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Coronary Artery Stenosis

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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: January 12, 2024Data 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

A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon

Inclusion Criteria

Exclusion Criteria

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease

Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study

Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

Evaluation of the Vivo Isar Stent System in Routine Clinical Practice

iFR Guided Coronary Artery Bypass Grafting Surgery