Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease

Study Overview
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Brief Summary
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This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this investigational device study.

Detailed Description
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Patients who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study. A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm dilatation catheters for pre-dilatation and will complete the study within the U.S. This equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.

Official Title
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Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease

Conditions
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Coronary Artery Disease, Heart Disease, Ischemic, Coronary Stenosis

Intervention / Treatment
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* Device: Artimes Pro Low Profile Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age; Willing and able to provide informed consent; Willing and able to meet all study requirements; Patients with symptomatic ischemic heart disease due to stenotic lesions or occlusions in coronary arteries that are amenable to percutaneous coronary interventions; Patients who tolerate DAPT Exclusion Criteria: A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated; LVEF < 30%; Evidence of an acute myocardial infarction within 72 hours of the intended index procedure; Planned treatment of unprotected left main disease; History of cerebral vascular accident (CVA) within 6 months prior to consideration for this study; Transient ischemic attack (TIA) within 6 months prior to consideration for this study; Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months prior to consideration for this study; History of bleeding diathesis or coagulopathy; Refuses blood transfusions; Any general contraindication to revascularization procedures; Pregnant or lactating; In the judgement of the investigator, patient is not a suitable candidate for this study.

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: 45 patients will be treated using the 1.0mm dilatation catheter and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated. Patients may be consented, enrolled and treated until the sample size is reached, with n=60 completing the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artimes Pro Low Profile Dilatation Catheter<br>Subjects who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study. | Device: Artimes Pro Low Profile Dilatation Catheter<br>* Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | Delivery of the catheter to and across lesion; inflation and deflation of the catheter; no vessel perforation, dissection or reduction in TIMI flow; and achievement of final TIMI flow grade 3. | Day 1 - Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated Adverse Events |  | Day 1 - Index Procedure |