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

Primary Purpose

Coronary Artery Disease, Heart Disease, Ischemic, Coronary Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artimes Pro Low Profile Dilatation Catheter
Sponsored by
Eminence Clinical Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Vincent Heart Center
  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artimes Pro Low Profile Dilatation Catheter

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Anticipated Adverse Events

Full Information

First Posted
September 29, 2017
Last Updated
June 9, 2020
Sponsor
Eminence Clinical Research, Inc.
Collaborators
BrosMed Medical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03301246
Brief Title
Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
January 29, 2020 (Actual)
Study Completion Date
May 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eminence Clinical Research, Inc.
Collaborators
BrosMed Medical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Heart Disease, Ischemic, Coronary Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artimes Pro Low Profile Dilatation Catheter
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Artimes Pro Low Profile Dilatation Catheter
Intervention Description
Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.
Primary Outcome Measure Information:
Title
Procedure Success
Description
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.
Time Frame
Day 1 - Index Procedure
Secondary Outcome Measure Information:
Title
Anticipated Adverse Events
Time Frame
Day 1 - Index Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasvinder Singh, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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