Status:
COMPLETED
Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease
Lead Sponsor:
Eminence Clinical Research, Inc.
Collaborating Sponsors:
BrosMed Medical Co., Ltd
Conditions:
Coronary Artery Disease
Heart Disease, Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03301246
Start Date
October 31 2018
End Date
May 8 2020
Last Update
June 11 2020
Active Locations (2)
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1
St. Vincent Heart Center
Indianapolis, Indiana, United States, 46290
2
Washington University in St. Louis
St Louis, Missouri, United States, 63110