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NCT Number: NCT03301246

Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Disease, Ischemic Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent Heart Center, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artimes Pro Low Profile Dilatation Catheter

Device

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

Primary outcomes

  1. Procedure Success

    Time frame: 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 outcomes

  1. Anticipated Adverse Events

    Time frame: Day 1 - Index Procedure

Sponsors and collaborators

Lead sponsor

Eminence Clinical Research, Inc.

Industry

Collaborators

  • BrosMed Medical Co., Ltd

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2017
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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