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Relationship Between Pressure and Flow Velocity on Coronary Physiology

Primary Purpose

Coronary Stenosis

Status
Withdrawn
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
combowire and IVUS
Sponsored by
Hyogo Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Stenosis focused on measuring Coronary Circulation

Eligibility Criteria

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

Inclusion Criteria:

  • A patient who are planned to do percutaneous coronary intervention for stenosis in the left circumflex artery without any lesions in other coronary arteries
  • Or a patient who is performed coronary angiography without significant stenosis lesion in 3-coronary vessel

Exclusion Criteria:

  • A patient with coronary stenosis with LAD
  • Hemodialysis
  • Acute coronary syndrome
  • Congestive heart failure
  • A patient with shock vitals

Sites / Locations

  • Hyogo College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Normal coronary artery

Arm Description

Outcomes

Primary Outcome Measures

Wave intensity

Secondary Outcome Measures

Coronary pressure
Flow velocity
Vessel diameter

Full Information

First Posted
December 24, 2014
Last Updated
August 1, 2018
Sponsor
Hyogo Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02330861
Brief Title
Relationship Between Pressure and Flow Velocity on Coronary Physiology
Official Title
Relationship Between Pressure and Flow Velocity on Coronary Physiology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hyogo Medical University

4. Oversight

5. Study Description

Brief Summary
Subjects are patients who are planned to do percutaneous coronary intervention for coronary stenosis in the left circumflex artery without other stenosis in the left ascending artery and the right coronary artery, or a patient with normal coronary artery. Immediately after coronary angiography or percutaneous coronary intervention, the investigators will evaluate for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary pressure and flow velocity with Combowire in each coronary segment. Also, they will assess coronary morphology by View It in each coronary segment.
Detailed Description
Combowire (Volcano Therapeutics Inc., CA, USA) is a 0.014 inch pressure/Doppler sensor-tipped-guidewire which can measure coronary pressure and flow velocity. View It (Terumo Co., Japan) is a guide catheter with intravascular ultrasound which can measure coronary morphology such as vessel diamter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
Keywords
Coronary Circulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal coronary artery
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
combowire and IVUS
Primary Outcome Measure Information:
Title
Wave intensity
Time Frame
Immediately after coronary angiography or percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
Coronary pressure
Time Frame
Immediately after coronary angiography or percutaneous coronary intervention
Title
Flow velocity
Time Frame
Immediately after coronary angiography or percutaneous coronary intervention
Title
Vessel diameter
Time Frame
Immediately after coronary angiography or percutaneous coronary intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient who are planned to do percutaneous coronary intervention for stenosis in the left circumflex artery without any lesions in other coronary arteries Or a patient who is performed coronary angiography without significant stenosis lesion in 3-coronary vessel Exclusion Criteria: A patient with coronary stenosis with LAD Hemodialysis Acute coronary syndrome Congestive heart failure A patient with shock vitals
Facility Information:
Facility Name
Hyogo College of Medicine
City
Nishinomiya
ZIP/Postal Code
6638501
Country
Japan

12. IPD Sharing Statement

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Relationship Between Pressure and Flow Velocity on Coronary Physiology

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