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

NCT03301246 | Completed DMC FDA Device

• 1 other identifier: BROS-CLIN-2017-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Heart Disease, Ischemic; Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anticipated Adverse Events

  Day 1 - Index Procedure

Study Arms (1)

Artimes Pro Low Profile Dilatation Catheter

EXPERIMENTAL

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

Interventions

Artimes Pro Low Profile Dilatation Catheter DEVICE

Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.

Artimes Pro Low Profile Dilatation Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eminence Clinical Research, Inc.: lead
• BrosMed Medical Co., Ltd: collaborator

Study Sites (2)

St. Vincent Heart Center

Indianapolis, Indiana, 46290, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jasvinder Singh, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 45 patients will be 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. Patients may be consented, enrolled and treated until the sample size is reached, with n=60 completing the study.

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: October 31, 2018
• Primary Completion: January 29, 2020
• Study Completion: May 8, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)