Coronary Artery Disease, Coronary Stenosis, Heart Disease, Ischemic
Conditions
Brief summary
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
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.
Interventions
DEVICEArtimes Pro Low Profile Dilatation Catheter
Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.
Sponsors
BrosMed Medical Co., Ltd
Eminence Clinical Research, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | Day 1 - Index Procedure | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Anticipated Adverse Events | Day 1 - Index Procedure |
Countries
United States
Outcome results
None listed