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

Eminence Clinical Research

Status: Completed

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

Treatments: Device: Artimes Pro Low Profile Dilatation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03301246

BROS-CLIN-2017-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Artimes Pro Low Profile Dilatation Catheter

Experimental group

Description:

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.

Treatment:

Device: Artimes Pro Low Profile Dilatation Catheter