Relationship Between Pressure and Flow Velocity on Coronary Physiology

NCT ID: NCT02330861

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal coronary artery

Group Type OTHER

combowire and IVUS

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

combowire and IVUS

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hyogo Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kenichi Fujii

Relationship between pressure and flow velocity on coronary physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hyogo College of Medicine

Nishinomiya, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KFujii-000000

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.