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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Stenosis; Heart Disease, Ischemic
• Intervention / Treatment: Device: Artimes Pro Low Profile Dilatation Catheter

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Artimes Pro Low Profile Dilatation Catheter; Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Anticipated Adverse Events	Day 1 - Index Procedure

Collaborators and Investigators

• Sponsor: Eminence Clinical Research, Inc.
• Collaborators: BrosMed Medical Co., Ltd
• Investigators: Principal Investigator: Jasvinder Singh, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2018
• Primary Completion (ACTUAL): January 29, 2020
• Study Completion (ACTUAL): May 8, 2020

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (ACTUAL): October 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Constriction, Pathologic; Coronary Stenosis; Dilatation, Pathologic
• Other Study ID Numbers: BROS-CLIN-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes