Coronary Artery StenosisPhase 4NCT01133015
Comparison of Fractional Flow Reserve and Intravascular Ultrasound
A Phase 4 study testing Fractional flow reserve and IVUS in people with Coronary Artery Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study will evaluate the relationship of Fractional Flow Reserve (FFR) and Minimal Lumen Area (MLA) by IntraVascular UltraSound (IVUS) by comparing the results of the both tests which is done as a part of the cardiac catheterization. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- Fractional flow reserve and IVUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Nov 2011
- Phase
- Phase 4
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-85
- Presence of at least one obstructive coronary artery stenosis as defined by:
- Previous catheterization or CT angiogram with any lesion 70% or greater
- Previous positive functional stress test (this does not include CTA alone)
- Ability and Willingness to provide informed consent
- Ability and Willingness to perform required follow up procedures
Who cannot join
- History of coronary artery bypass graft surgery
- Previously revascularized lesion
- Creatinine>1.6 mg/dL or GFR<30 pre-procedure per institutional standards
- Known Pregnancy
- Inability to perform CTA
- Arrhythmia precluding diagnostic CT examination
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- Contrast agent allergy that cannot be adequately premedicated
- Severe PVD precluding cardiac catheterization
- Patient not a candidate for IVUS and FFR
- Inability or unwillingness to provide informed consent
- Inability or unwillingness to perform required follow up procedures
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university hospital
Seoul, 110-744
Bon-kown Koo, MD/PhD, 82-2-2072-2062, bkkoo@snu.ac.kr
Bon-kwon Koo, MD/PhD
About this study
Official title: Comparison of Fractional Flow Reserve and Minimal Luminal Area by Intravascular Ultrasound in Evaluating Intermediate Coronary Artery Stenosis in Each Coronary Artery
This study will evaluate the relationship of Fractional Flow Reserve (FFR) and Minimal Lumen Area (MLA) by IntraVascular UltraSound (IVUS) by comparing the results of the both tests which is done as a part of the cardiac catheterization.
Read the detailed description
Invasive X-ray coronary angiography remains the "reference standard" for the evaluation of coronary artery stenoses. Recently, intravascular ultrasound (IVUS) has been introduced as an invasive method for the evaluation of coronary artery stenoses and has been shown to be highly accurate in stenosis detection when compared to X-ray angiography. While invasive X-ray angiography and IVUS evaluate morphological features of coronary arterial plaques, fractional flow reserve (FFR) is an invasive measure of the hemodynamic significance of a stenosis obtained in the catheterization laboratory by measuring changes in intracoronary arterial pressure before and after maximal vasodilation induced by intravenous adenosine. An FFR value less than 0.75 has been shown to predict ischemia in vascular beds distal to the stenosis by radionuclide perfusion modalities and has been shown to be associated with worse outcomes. Therefore, FFR is considered to be an invasive hemodynamic "reference standard" for the evaluation of the hemodynamic significance of coronary arterial stenoses. While IVUS can provide additional morphological information in intermediate stenoses, it can not provide further functional information.
We are currently conducting investigation in the validation of IVUS against FFR in intermediate coronary artery stenoses in each coronary arteries. However, the difference of the values of IVUS data in each coronary artery, eg. left anterior descending artery or right coronary artery, has not been validated against invasive hemodynamic measurements of fractional flow reserve in patients with intermediate stenoses by invasive X-ray angiography. We hypothesize that IVUS-derived measurements are interpreted differently in each coronary arteries in the diagnosis of hemodynamically significant coronary artery stenoses, using FFR as the reference standard in patients with coronary artery stenoses 40%< and <70%.
- Conditions
- Coronary Artery Stenosis
- Being tested
- Fractional flow reserve, IVUS
- Keywords
- FFR, IVUS, MLA
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserveDevice
Also called RADI pressure wire
Fractional flow reserve measured by pressure wire
IVUSDevice
Also called Volcano IVUS, boston scientific
intravascular ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Intermediate lesion | Experimental | Intermediate lesion will be evaluated by both IVUS and FFR Receives: Device: Fractional flow reserve; Device: IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
lumen area
lumen area cut-off that can predict the functional significance of a lesion
Measured: 1 day
Secondary outcomes (2)
angiographic stenosis, % plaque area
angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions
Measured: 1 day
CT measurement
Diagnostic accuracy of CT derived parameters
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMar 2009
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Keimyung University, Inje University, Ajou University
- Investigators
- Bon-kwon Koo, MD/PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133015
- Sponsor's protocol ID
- 1001-009-305
- Status last verified
- Jul 2011
- First submitted
- 24 May 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koo BK, Yang HM, Doh JH, Choe H, Lee SY, Yoon CH, Cho YK, Nam CW, Hur SH, Lim HS, Yoon MH, Park KW, Na SH, Youn TJ, Chung WY, Ma S, Park SK, Kim HS, Tahk SJ. Optimal intravascular ultrasound criteria and their accuracy for defining the functional significance of intermediate coronary stenoses of different locations. JACC Cardiovasc Interv. 2011 Jul;4(7):803-11. doi: 10.1016/j.jcin.2011.03.013.
PubMed 21777890
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fractional Flow Reserve and Minimal Luminal Area by Intravascular Ultrasound in Evaluating Intermediate Coronary Artery Stenosis in Each Coronary Artery
- ClinicalTrials.gov ID
- NCT01133015
- Acronym / sponsor ID
- 1001-009-305
- Conditions
- Coronary Artery Stenosis
- Keywords
- FFR, IVUS, MLA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Keimyung University, Inje University, Ajou University
- Study start
- Mar 2009
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 28 May 2010 (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.
This study will evaluate the relationship of Fractional Flow Reserve (FFR) and Minimal Lumen Area (MLA) by IntraVascular UltraSound (IVUS) by comparing the results of the both tests which is done as a part of the cardiac catheterization.
Detailed description
Invasive X-ray coronary angiography remains the "reference standard" for the evaluation of coronary artery stenoses. Recently, intravascular ultrasound (IVUS) has been introduced as an invasive method for the evaluation of coronary artery stenoses and has been shown to be highly accurate in stenosis detection when compared to X-ray angiography. While invasive X-ray angiography and IVUS evaluate morphological features of coronary arterial plaques, fractional flow reserve (FFR) is an invasive measure of the hemodynamic significance of a stenosis obtained in the catheterization laboratory by measuring changes in intracoronary arterial pressure before and after maximal vasodilation induced by intravenous adenosine. An FFR value less than 0.75 has been shown to predict ischemia in vascular beds distal to the stenosis by radionuclide perfusion modalities and has been shown to be associated with worse outcomes. Therefore, FFR is considered to be an invasive hemodynamic "reference standard" for the evaluation of the hemodynamic significance of coronary arterial stenoses. While IVUS can provide additional morphological information in intermediate stenoses, it can not provide further functional information.
We are currently conducting investigation in the validation of IVUS against FFR in intermediate coronary artery stenoses in each coronary arteries. However, the difference of the values of IVUS data in each coronary artery, eg. left anterior descending artery or right coronary artery, has not been validated against invasive hemodynamic measurements of fractional flow reserve in patients with intermediate stenoses by invasive X-ray angiography. We hypothesize that IVUS-derived measurements are interpreted differently in each coronary arteries in the diagnosis of hemodynamically significant coronary artery stenoses, using FFR as the reference standard in patients with coronary artery stenoses 40%< and <70%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermediate lesion | Experimental | Device: Fractional flow reserve, Device: IVUSIntermediate lesion will be evaluated by both IVUS and FFR |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 21-85
- Presence of at least one obstructive coronary artery stenosis as defined by:
- Previous catheterization or CT angiogram with any lesion 70% or greater
- Previous positive functional stress test (this does not include CTA alone)
- Ability and Willingness to provide informed consent
Key exclusion criteria (11 listed)
- History of coronary artery bypass graft surgery
- Previously revascularized lesion
- Creatinine>1.6 mg/dL or GFR<30 pre-procedure per institutional standards
- Known Pregnancy
- Inability to perform CTA
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 |
|---|---|---|
| Fractional flow reserveAlso: RADI pressure wireFractional flow reserve measured by pressure wire | Device | Intermediate lesion |
| IVUSAlso: Volcano IVUS, boston scientificintravascular ultrasound | Device | Intermediate lesion |
Primary outcome
lumen area
Time frame: 1 day
lumen area cut-off that can predict the functional significance of a lesion
2 secondary outcomes
angiographic stenosis, % plaque area
Time frame: 1 day
CT measurement
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
- Derived from this study: PubMed 21777890Koo BK, Yang HM, Doh JH, Choe H, Lee SY, Yoon CH, Cho YK, Nam CW, Hur SH, Lim HS, Yoon MH, Park KW, Na SH, Youn TJ, Chung WY, Ma S, Park SK, Kim HS, Tahk SJ. Optimal intravascular ultrasound criteria and their accuracy for defining the functional significance of intermediate coronary stenoses of different locations. JACC Cardiovasc Interv. 2011 Jul;4(7):803-11. doi: 10.1016/j.jcin.2011.03.013.
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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.
Bon-kwon Koo, MD/PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fractional flow reserve and IVUS in people with Coronary Artery Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Jul 2011. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bon-kwon Koo, MD/PhD (82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lumen area (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01133015, which also lists 1 linked publication.
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 21 Jul 2011.