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

Not Applicable

Completed

• Conditions: Heart Disease, Ischemic; Coronary Stenosis; Coronary Artery Disease
• Interventions: Device: Artimes Pro Low Profile Dilatation Catheter

• Registration Number: NCT03301246
• Lead Sponsor: Eminence Clinical Research, Inc.

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.

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-04
• Study Start: 2018-10-31
• Primary Completion: 2020-01-29
• Study Completion: 2020-05-08
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Artimes Pro Low Profile Dilatation Catheter	Artimes Pro Low Profile Dilatation Catheter	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Anticipated Adverse Events	Day 1 - Index Procedure

Trial Locations

Locations (2)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

St. Vincent Heart Center; 🇺🇸 Indianapolis, Indiana, United States