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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301246
• Other study ID #: BROS-CLIN-2017-01
• Status: Completed
• Phase: N/A
• Start date: October 31, 2018
• Est. completion date: May 8, 2020

Study information

• Verified date: June 2020
• Source: Eminence Clinical Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 8, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Stenosis
• Heart Disease, Ischemic
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Artimes Pro Low Profile Dilatation Catheter
Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.

Locations

Country	Name	City	State
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Eminence Clinical Research, Inc.	BrosMed Medical Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Success	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.	Day 1 - Index Procedure
Secondary	Anticipated Adverse Events		Day 1 - Index Procedure