Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease
Completed · Not applicable
Conditions studied: Coronary Artery Disease, Heart Disease, Ischemic, Coronary Stenosis
In brief
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.
Key facts
- Study ID
- NCT03301246
- Run by
- Eminence Clinical Research, Inc.
- People needed
- 60
- Starts
- 2018-10-31
- Expected to finish
- 2020-05-08
- Last updated by the study team
- 2020-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- St. Vincent Heart Center — Indianapolis, Indiana, United States
- Washington University in St. Louis — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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