Coronary Artery DiseaseNCT01409577
Outcome of FFR-guided Intervention Strategy
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The investigator will evaluate the clinical outcomes of the patients in whom the treatment strategy for their coronary stenosis were determined by fractional flow reserve measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,500 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Mar 2011to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate coronary stenosis by visual estimation
Who may be able to join
- Coronary stenosis
- Successful fractional flow reserve measurement
Who cannot join
- Contraindication to adenosine
- Expected life expectance < 1year
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Ilsan Paik hospital
Ilsan
Joon-Hyung Do, MD, Phd
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Bon-Kwon Koo, MD, PhD
About this study
Official title: Clinical Outcome of Fractional Flow Reserve-guided Coronary Intervention Strategy in Koreans
The investigator will evaluate the clinical outcomes of the patients in whom the treatment strategy for their coronary stenosis were determined by fractional flow reserve measurement.
Read the detailed description
Inclusion criteria
- Coronary stenosis
- Successful measurement of fractional flow reserve
Clinical outcomes
- Death
- Cardiac death
- Target lesion revascularization
- Target vessel revascularization
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary stenosis, stent, fractional flow reserve
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FFR | Patients with intermediate coronary stenosis Patients with successful fractional flow measurement Feasible > 9months clinical follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term MACE
Cardiac death, MI, target vessel revascularization, target lesion revascularization
Measured: 5 years
Secondary outcomes (1)
Short-term MACE
Cardiac death, MI, TLR/TVR
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ajou University, Keimyung University Dongsan Medical Center, Inje University
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409577
- Sponsor's protocol ID
- H1102-032-350
- Status last verified
- Nov 2011
- First submitted
- 2 Aug 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Fractional Flow Reserve-guided Coronary Intervention Strategy in Koreans
- ClinicalTrials.gov ID
- NCT01409577
- Acronym / sponsor ID
- H1102-032-350
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary stenosis, stent, fractional flow reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ajou University, Keimyung University Dongsan Medical Center, Inje University
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 4 Aug 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 investigator will evaluate the clinical outcomes of the patients in whom the treatment strategy for their coronary stenosis were determined by fractional flow reserve measurement.
Detailed description
Inclusion criteria
- Coronary stenosis
- Successful measurement of fractional flow reserve
Clinical outcomes
- Death
- Cardiac death
- Target lesion revascularization
- Target vessel revascularization
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFR | – | –Patients with intermediate coronary stenosis Patients with successful fractional flow measurement Feasible > 9months clinical follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate coronary stenosis by visual estimation
Key inclusion criteria (2 listed)
- Coronary stenosis
- Successful fractional flow reserve measurement
Key exclusion criteria (2 listed)
- Contraindication to adenosine
- Expected life expectance < 1year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term MACE
Time frame: 5 years
Cardiac death, MI, target vessel revascularization, target lesion revascularization
1 secondary outcome
Short-term MACE
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 2 sites 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 2 inclusion and 2 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 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Long-term MACE (time frame: 5 years). 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 22 Nov 2011.