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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:October 31, 2018
End Date:May 30, 2019
Contact:Pam DiCamillo, LVN, CRCC
Email:PDiCamillo@ECR-Inc.com
Phone:903-352-2714

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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

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.

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.

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.
We found this trial at
2
sites
Indianapolis, Indiana 46290
Principal Investigator: Michael W Ball, MD
Phone: 317-583-6303
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Indianapolis, IN
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Saint Louis, Missouri 63110
Principal Investigator: Jasvindar Singh, MD
Phone: 314-747-1612
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Saint Louis, MO
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