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NCT02330861 Clinical Trial

Relationship Between Pressure and Flow Velocity on Coronary Physiology

Coronary Stenosis Clinical Trial

Official title:
Relationship Between Pressure and Flow Velocity on Coronary Physiology

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02330861
Other study ID # KFujii-000000
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date February 2017

Study information
Verified date February 2017
Source Hyogo College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• combowire and IVUS

Locations
Country Name City State
Japan Hyogo College of Medicine Nishinomiya

Sponsors (1)
Lead Sponsor Collaborator
Hyogo College of Medicine

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wave intensity Immediately after coronary angiography or percutaneous coronary intervention
Secondary Coronary pressure Immediately after coronary angiography or percutaneous coronary intervention
Secondary Flow velocity Immediately after coronary angiography or percutaneous coronary intervention
Secondary Vessel diameter Immediately after coronary angiography or percutaneous coronary intervention
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