Scoreflex NC - Scoring PTCA Catheter

Study Overview
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Brief Summary
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A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention. Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.

Official Title
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Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arteries During Percutaneous Coronary Intervention.

Conditions
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Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases

Intervention / Treatment
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* Device: Scoreflex NC Scoring PTCA catheter


Participation Criteria
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Eligibility Criteria
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Clinical Inclusion Criteria Subject is ≥ 18 years of age. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study. Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, stable / unstable angina or silent ischemia. Angiographic Inclusion Criteria Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO). The non-target lesion must be located in different coronary artery from the Target lesion. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. Clinical Exclusion Criteria: Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated. Subject with known diagnosis of STEMI or NSTEMI at index presentation or within 7 days of study screening. Subject with known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days before index procedure. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure. A serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure. Cerebrovascular accident (CVA) within the past 6 months. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months. Subject has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary) Target lesion located within an arterial or saphenous vein graft or graft anastomosis Angiographic Exclusion Criteria More than two lesions requiring treatment. Target lesion longer than 30 mm by visual estimation. Extreme angulation (90º or greater) proximal to or within the target lesion. Previous percutaneous intervention of lesions in a target vessel (including side branches) conducted within 9 months before the study procedure and located within 10 mm from the current target lesion. Target lesion demonstrating severe dissection prior to planned deployment of the Scoreflex NC device Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis) Coronary artery spasm of the target vessel in the absence of a significant stenosis. Target lesion with angiographic presence of probable or definite thrombus. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter. Non-target lesion to be treated during the index procedure meets any of the following criteria: Located within a bypass graft (venous or arterial) Left main location Chronic total occlusion Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent) Treatment not deemed a clinical angiographic success

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scoreflex NC Scoring PTCA Catheter<br>Single arm with investigational Scoreflex NC Scoring PTCA catheters | Device: Scoreflex NC Scoring PTCA catheter<br>* To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Device Procedural Success | Device procedural success consisting of the following: Successful delivery, inflation, deflation, and withdrawal of the study balloon No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure | Peri-procedural (at Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Angiographic Procedural Success | Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting | Peri-procedural (at Day 0) | 
| Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | In-hospital Major Adverse Cardiac Events (MACE), a composite of: All death (cardiac and non-cardiac) Myocardial infarction (MI) Target Lesion Revascularization (TLR), clinically indicated | Endpoints will be measured through hospital discharge (expected to be within 24 hours) | 
| Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel | In-hospital stent thrombosis (ST) within the Target Vessel | Endpoint will be measured through hospital discharge (expected to be within 24 hours) | 
| Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) | Clinically Significant Arrhythmias (Requiring Intervention) | Endpoint will be measured through hospital discharge (expected to be within 24 hours) | 
| Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture | Occurrence of Scoreflex NC Study Balloon rupture | Peri-procedural | 
| Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA)) | Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA). Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline. | Peri-procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases