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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis

Intervention / Treatment
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* Device: Lacrosse NSE ALPHA coronary dilatation catheter


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA General inclusion criteria: Age 18 years or older. Willing to provide written informed consent and written HIPAA authorization prior to initiation of study-related procedures. Agree to not participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study. Clinical evidence of ischemic heart disease, stable/unstable angina, or silent ischemia. Acceptable candidate for PCI and emergency coronary artery bypass grafting and is planned for possible PTCA and/or stent placement. Angiographic inclusion criteria: De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis. A maximum of two lesions, including at least one target lesion, in single or double vessel coronary artery disease. If two target lesions are defined, then no non-target lesions can be treated. 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. Target lesion(s) must have a reference vessel diameter between 2.0 mm and 4.0 mm by visual estimation. Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) >50% by visual estimation and a fractional flow reserve (FFR) of <0.80 or resting full-cycle ratio (RFR) or instantaneous wave-free ratio (iFR) <0.9. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion; must not, in the opinion of the investigator, impact the conduct or completion of the index procedure; and must be deemed a clinical angiographic success as visually assessed by the investigator. EXLUSION CRITERIA General exclusion criteria: 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. 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. Known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days prior to index procedure. Planned target lesion treatment with atherectomy (rotational, orbital or laser), cutting balloon, thrombectomy, lithotripsy or an unapproved device during the index procedure. Serum creatinine >2.0 mg/dl within 7 days prior to the index procedure. Cerebrovascular accident within 6 months prior to the index procedure. Active peptic ulcer or active gastrointestinal bleeding within 6 months prior to the index procedure. 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). Target lesion located within a bypass graft (venous or arterial) or graft anastomosis. 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). Target lesion(s) with complete total occlusion defined as the complete obstruction of a native coronary artery, exhibiting TIMI 0 or TIMI 1 flow, with an occlusion duration of at least 3 months. Unstable hemodynamics or shock. Other medical condition which might, in the opinion of the investigator, put the patient at risk or confound the results of the study. Angiographic exclusion criteria Target lesion(s) longer than 32 mm by visual estimation. Extreme angulation (90º or greater) within 5 mm of the target lesion. Target lesion(s) demonstrating flow limiting dissection (NHLBI Grade C or higher) prior to deployment of the Lacrosse NSE ALPHA. Unprotected left main coronary artery disease (>50% diameter stenosis). Coronary artery spasm of the target vessel in the absence of a significant stenosis. Target lesion(s) with angiographic presence of probable or definite thrombus. Target lesion(s) involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter. Target lesion(s) located in bifurcation beyond stent struts. Target lesion(s) located distal to an implanted stent. Target lesion(s) with stent damage. Non-target lesion that meets any of the following criteria: Located within a bypass graft (venous or arterial) Located in an unprotected left main coronary artery A CTO Involves a bifurcation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, multi-center, single arm clinical study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacrosse NSE ALPHA percutaneous coronary intervention (PCI)<br>Percutaneous coronary intervention (PCI) in which at least one Lacrosse NSE ALPHA device is used. | Device: Lacrosse NSE ALPHA coronary dilatation catheter<br>* The Lacrosse NSE ALPHA is a rapid exchange percutaneous transluminal coronary angioplasty balloon catheter with non-slip element nylon threads that focus dilatation force to reduce balloon slippage during inflation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success | Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and No evidence of device-related vessel perforation, flow limiting dissection (grade C or higher per Clinical Events Committee (CEC) adjudication) or reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline (per core laboratory assessment); and Final TIMI flow grade of 3 at the conclusion of the PCI procedure per core laboratory assessment. This endpoint will be presented as the proportion of subjects experiencing device procedural success. | Procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with angiographic procedural success | Defined as final diameter stenosis ≤50% in at least one of the Lacrosse NSE ALPHA attempted lesions following completion of the interventional procedure, including adjunctive stenting. | Procedural | 
| Percentage of subjects with a MACE | Defined as a composite of: All-cause death Myocardial infarction (MI) Clinically indicated target lesion revascularization (TLR) | At hospital discharge, an average of 1 day after procedure | 
| Percentage of subjects with stent thrombosis within the target vessel(s) | Using ARC-2 definitions for definite & probable | At hospital discharge, an average of 1 day after procedure | 
| Percentage of subjects with a clinically significant arrythmia | Defined as arrhythmia those requiring intervention | At hospital discharge, an average of 1 day after procedure | 
| Occurrence of Lacrosse NSE ALPHA balloon rupture | Per device deficiency eCRF | Procedural | 
| Change in minimum lumen diameter (MLD) following use of the Lacrosse NSE ALPHA catheter | Measured by quantitative coronary angiography (QCA) | Procedural | 
| Device procedural success (per target lesion) | Successful delivery, inflation, deflation, and withdrawal of the study balloon; and no evidence of device-related vessel perforation, flow limiting dissection (grade C or higher) or reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline; and final TIMI flow grade of 3 at the conclusion of the PCI procedure. This endpoint will be presented as the proportion of target lesions experiencing device procedural success. | Procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary dilation catheter, Percutaneous coronary artery dilatation, Non-slip Element balloon, Restenosis