Coronary StenosisNCT02330861
Relationship Between Pressure and Flow Velocity on Coronary Physiology
A study testing combowire and IVUS in people with Coronary Stenosis, run by Hyogo Medical University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- combowire and IVUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A patient with coronary stenosis with LAD
- Hemodialysis
- Acute coronary syndrome
- Congestive heart failure
- A patient with shock vitals
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Coronary Stenosis
- Being tested
- combowire and IVUS
- Keywords
- Coronary Circulation
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combowire and IVUSDevice
| Study group | Role | What they receive |
|---|---|---|
| Normal coronary artery | Other | Not described Receives: Device: combowire and IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wave intensity
Measured: Immediately after coronary angiography or percutaneous coronary intervention
Secondary outcomes (3)
Coronary pressure
Measured: Immediately after coronary angiography or percutaneous coronary intervention
Flow velocity
Measured: Immediately after coronary angiography or percutaneous coronary intervention
Vessel diameter
Measured: Immediately after coronary angiography or percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyogo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenichi Fujii, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330861
- Sponsor's protocol ID
- KFujii-000000
- Status last verified
- Feb 2017
- First submitted
- 24 Dec 2014
- Last updated
- 2 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Pressure and Flow Velocity on Coronary Physiology
- ClinicalTrials.gov ID
- NCT02330861
- Acronym / sponsor ID
- KFujii-000000
- Conditions
- Coronary Stenosis
- Keywords
- Coronary Circulation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hyogo Medical UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal coronary artery | Other | Device: combowire and IVUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- A patient with coronary stenosis with LAD
- Hemodialysis
- Acute coronary syndrome
- Congestive heart failure
- A patient with shock vitals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combowire and IVUS | Device | Normal coronary artery |
Primary outcome
Wave intensity
Time frame: Immediately after coronary angiography or percutaneous coronary intervention
3 secondary outcomes
Coronary pressure
Time frame: Immediately after coronary angiography or percutaneous coronary intervention
Flow velocity
Time frame: Immediately after coronary angiography or percutaneous coronary intervention
Vessel diameter
Time frame: Immediately after coronary angiography or percutaneous coronary intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combowire and IVUS in people with Coronary Stenosis, run by Hyogo Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wave intensity (time frame: Immediately after coronary angiography or percutaneous coronary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.