Relationship Between Pressure and Flow Velocity on Coronary Physiology

Not Applicable

Withdrawn

• Conditions: Coronary Stenosis
• Interventions: Device: combowire and IVUS

• Registration Number: NCT02330861
• Lead Sponsor: Hyogo Medical University

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-24
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-05
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal coronary artery	combowire and IVUS	-

Primary Outcome Measures

Name	Time	Method
Wave intensity	Immediately after coronary angiography or percutaneous coronary intervention

Secondary Outcome Measures

Name	Time	Method
Vessel diameter	Immediately after coronary angiography or percutaneous coronary intervention
Coronary pressure	Immediately after coronary angiography or percutaneous coronary intervention
Flow velocity	Immediately after coronary angiography or percutaneous coronary intervention

Trial Locations

Locations (1)

Hyogo College of Medicine; 🇯🇵 Nishinomiya, Japan