Coronary Artery StenosisNCT01335659
Main Branch Versus Side Branch Ostial Lesion
An observational study of Coronary Artery Stenosis, run by Seoul National University Hospital.
Trial summary
The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions. 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
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2011
- Phase
- Observational
- 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
Study population: from september 2009 to january 2011 patient who are undergone coronary angiography,IVUS and FFR for the evaluation of coronary artery disease at SNUH
Who may be able to join
- Age 21-85
- Presence of at least one obstructive coronary artery stenosis at coronary ostium as defined by:
- Previous catheterization with any coronary ostium lesion 50% or greater
- 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
- left main coronary ostial lesion
- significant stenosis at proximal or distal part of coronary ostium lesion
- ostial lesion related to infarcton
- Creatinine>1.6 mg/dL or GFR<30 pre-procedure per institutional standards
- Ejection fraction lower than 40%
Show all 12Show fewer
- Known Pregnancy
- Arrhythmia
- Contrast agent allergy that cannot be adequately premedicated
- Patient not a candidate for IVUS and FFR
- Inability or unwillingness to provide informed consent
- Inability or unwillingness to perform required follow up procedures
About this study
Official title: Relationship Between Fractional Flow Reserve and Coronary Angiography/Intravascular Ultrasound Parameters in Ostial Lesions: Major Coronary Ostial Lesions Versus Side Branch Ostial Lesions
The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.
Read the detailed description
Angiographic evaluation for ostial lesions is reported to be inaccurate in the assessment of the functional and clinical significance of a lesion. The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.
- Conditions
- Coronary Artery Stenosis
- Being tested
- Fractional flow reserve, IVUS
- Keywords
- FFR, IVUS, QCA
- 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(Radi Medical Systems, Uppsala, Sweden)
Fractional flow reserve measured by pressure wire
IVUSDevice
Also called iLab® Ultrasound Imaging System(Boston Scientific/SCIMED, Minneapolis, MN, USA)
intravascular ultrasound
:IVUS was performed in a standard fashion using an automated motorized pullback system (0.5mm/s) with commercially available imaging catheter
| Study group | Role | What they receive |
|---|---|---|
| ostial lesion | ostial lesion will be evaluated by 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 at ostial lesion
Measured: 1 day
Secondary outcomes (1)
angiographic stenosis, % plaque area
angiographic and intravascular ultrasound parameters at ostial lesions of each major branch and side branch.
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 posted14 Apr 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bon-kwon Koo, MD/PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335659
- Sponsor's protocol ID
- Bif_3
- Status last verified
- Jul 2011
- First submitted
- 7 Apr 2011
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Koh JS, Koo BK, Kim JH, Yang HM, Park KW, Kang HJ, Kim HS, Oh BH, Park YB. Relationship between fractional flow reserve and angiographic and intravascular ultrasound parameters in ostial lesions: major epicardial vessel versus side branch ostial lesions. JACC Cardiovasc Interv. 2012 Apr;5(4):409-15. doi: 10.1016/j.jcin.2012.01.013.
PubMed 22516397
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
- Relationship Between Fractional Flow Reserve and Coronary Angiography/Intravascular Ultrasound Parameters in Ostial Lesions: Major Coronary Ostial Lesions Versus Side Branch Ostial Lesions
- ClinicalTrials.gov ID
- NCT01335659
- Acronym / sponsor ID
- Bif_3
- Conditions
- Coronary Artery Stenosis
- Keywords
- FFR, IVUS, QCA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Apr 2011 (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.
The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.
Detailed description
Angiographic evaluation for ostial lesions is reported to be inaccurate in the assessment of the functional and clinical significance of a lesion. The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ostial lesion | – | Device: Fractional flow reserve, Device: IVUSostial lesion will be evaluated by IVUS and FFR |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- from september 2009 to january 2011 patient who are undergone coronary angiography,IVUS and FFR for the evaluation of coronary artery disease at SNUH
Key inclusion criteria (5 listed)
- Age 21-85
- Presence of at least one obstructive coronary artery stenosis at coronary ostium as defined by:
- Previous catheterization with any coronary ostium lesion 50% or greater
- Ability and Willingness to provide informed consent
- Ability and Willingness to perform required follow up procedures
Key exclusion criteria (12 listed)
- History of coronary artery bypass graft surgery
- left main coronary ostial lesion
- significant stenosis at proximal or distal part of coronary ostium lesion
- ostial lesion related to infarcton
- Creatinine>1.6 mg/dL or GFR<30 pre-procedure per institutional standards
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 Wire(Radi Medical Systems, Uppsala, Sweden)Fractional flow reserve measured by pressure wire | Device | ostial lesion |
| IVUSAlso: iLab® Ultrasound Imaging System(Boston Scientific/SCIMED, Minneapolis, MN, USA)intravascular ultrasound :IVUS was performed in a standard fashion using an automated motorized pullback system (0.5mm/s) with commercially available imaging catheter | Device | ostial lesion |
Primary outcome
lumen area
Time frame: 1 day
lumen area at ostial lesion
1 secondary outcome
angiographic stenosis, % plaque area
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
- Derived from this study: PubMed 22516397Koh JS, Koo BK, Kim JH, Yang HM, Park KW, Kang HJ, Kim HS, Oh BH, Park YB. Relationship between fractional flow reserve and angiographic and intravascular ultrasound parameters in ostial lesions: major epicardial vessel versus side branch ostial lesions. JACC Cardiovasc Interv. 2012 Apr;5(4):409-15. doi: 10.1016/j.jcin.2012.01.013.
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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 study director
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Stenosis, run by Seoul National University Hospital.
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 5 inclusion and 12 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: finished, 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 NCT01335659, 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.