Coronary Artery StenosisPhase 4FAVORNCT01175863
Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease
A Phase 4 study testing Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) and Pressure wire(Radi Medical Systems) in people with Coronary Artery Stenosis, run by Ajou University School of Medicine at 8 sites in South Korea.
Trial summary
This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) and Pressure wire(Radi Medical Systems)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Feb 2010to May 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical indication:
- Patients with angina or patients with documented silent ischemia
- Patients who are eligible for intracoronary stenting
- Age > 18 years old, < 75 years old
- Angiographic indication:
- Intermediate coronary artery disease (30-70% diameter stenosis) by visual estimation
- Reference vessel diameter ≥ 3.0mm by visual estimation
Who cannot join
- Acute or old myocardial infarction
- Previous coronary artery bypass graft
- Left main disease (≥ 50% stenosis)
- In-stent restenosis lesion
- Chronic total occlusion
- Low ejection fraction (< 40 %)
Show all 12Show fewer
- Graft vessel lesion
- History of bleeding diathesis or coagulopathy
- Limited life-expectancy (less than 1 year) due to combined serious disease
- Contra-indication to heparin, everolimus
- Contraindication to aspirin, clopidogrel or cilostazol
- Pregnant
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Keimyung university Dongsan medical center
Daegu
Inje University
Ilsan
Korea University Guro Hospital
Seoul
Seoul National University Boramae Medical Center
Seoul
Seoul national university hospital
Seoul
Yensei University Gangnam Severance Hospital
Seoul
Ajou University Medical Center
Suwon
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
Wŏnju
About this study
Official title: Fractional Flow Reserve- And Intra-vascular Ultrasound-Guided Percutaneous Coronary Intervention With Drug-Eluting Stents in Intermediate Coronary Artery Lesion (FAVOR Study)
This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.
Read the detailed description
This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.
- Conditions
- Coronary Artery Stenosis
- Being tested
- Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound), Pressure wire(Radi Medical Systems)
- Keywords
- intravascular ultrasound, fractional flow reserve
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)Device
Also called Galaxy (Boston Scientific), Virtual histology (Volcano)
minimal lumen area on Intravascular ultrasound
Pressure wire(Radi Medical Systems)Device
Also called Pressure wire (Radi Medical Systems)
Fractional flow reserve measured by pressure wire
| Study group | Role | What they receive |
|---|---|---|
| Intravascular ultrasound | Active comparator | Not described Receives: Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) |
| Fractional flow reserve | Active comparator | Not described Receives: Device: Pressure wire(Radi Medical Systems) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Measured: 1 year
Secondary outcomes (13)
Cardiac death
Measured: 1 and 2 years
Myocardial infarction (MI)
Measured: 1 and 2 years
Composite of cardiac death or myocardial infarction
Measured: 1 and 2 years
Target vessel revascularization (ischemia- and clinically-driven)
Measured: 1 and 2 years
Target lesion revascularization (ischemia- and clinically-driven)
Measured: 1 and 2 years
Stent thrombosis (Academic Research Consortium criteria)
Measured: 1 and 2 years
In-stent and in-segment late loss on angiographic follow-up
Measured: 1 year
In-stent and in-segment restenosis rate
Measured: 1 year
Incidence and angiographic pattern of restenosis
Measured: 1 year
Canadian Cardiovascular Society Classification status
Measured: 1 and 2 years
The number of anti-angina medication
Measured: 1 and 2 years
Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group
Measured: Baseline (day 0)
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Jea Tahk, Ajou University School of Medicine
- Investigators
- Sejung-Jea Tahk, MD, PhD, Principal investigator, Ajou University Medical Center, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175863
- Sponsor's protocol ID
- FAVOR
- Acronym
- FAVOR
- Status last verified
- Feb 2014
- First submitted
- 3 Aug 2010
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Flow Reserve- And Intra-vascular Ultrasound-Guided Percutaneous Coronary Intervention With Drug-Eluting Stents in Intermediate Coronary Artery Lesion (FAVOR Study)
- ClinicalTrials.gov ID
- NCT01175863
- Acronym / sponsor ID
- FAVOR / FAVOR
- Conditions
- Coronary Artery Stenosis
- Keywords
- intravascular ultrasound, fractional flow reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 5 Aug 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 is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.
Detailed description
This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular ultrasound | Active comparator | Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) |
| Fractional flow reserve | Active comparator | Device: Pressure wire(Radi Medical Systems) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with angina or patients with documented silent ischemia
- Patients who are eligible for intracoronary stenting
- Age > 18 years old, < 75 years old
- Intermediate coronary artery disease (30-70% diameter stenosis) by visual estimation
- Reference vessel diameter ≥ 3.0mm by visual estimation
Key exclusion criteria (12 listed)
- Acute or old myocardial infarction
- Previous coronary artery bypass graft
- Left main disease (≥ 50% stenosis)
- In-stent restenosis lesion
- Chronic total occlusion
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 |
|---|---|---|
| Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)Also: Galaxy (Boston Scientific), Virtual histology (Volcano)minimal lumen area on Intravascular ultrasound | Device | Intravascular ultrasound |
| Pressure wire(Radi Medical Systems)Also: Pressure wire (Radi Medical Systems)Fractional flow reserve measured by pressure wire | Device | Fractional flow reserve |
Primary outcome
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Time frame: 1 year
13 secondary outcomes
Cardiac death
Time frame: 1 and 2 years
Myocardial infarction (MI)
Time frame: 1 and 2 years
Composite of cardiac death or myocardial infarction
Time frame: 1 and 2 years
Target vessel revascularization (ischemia- and clinically-driven)
Time frame: 1 and 2 years
Target lesion revascularization (ischemia- and clinically-driven)
Time frame: 1 and 2 years
Stent thrombosis (Academic Research Consortium criteria)
Time frame: 1 and 2 years
In-stent and in-segment late loss on angiographic follow-up
Time frame: 1 year
In-stent and in-segment restenosis rate
Time frame: 1 year
Incidence and angiographic pattern of restenosis
Time frame: 1 year
Canadian Cardiovascular Society Classification status
Time frame: 1 and 2 years
The number of anti-angina medication
Time frame: 1 and 2 years
Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group
Time frame: Baseline (day 0)
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
Related trials for Coronary Artery Stenosis
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure
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.
Sejung-Jea Tahk, MD, PhD principal investigator
Ajou University Medical Center, Ajou University School of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) and Pressure wire(Radi Medical Systems) in people with Coronary Artery Stenosis, run by Ajou University School of Medicine at 8 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 7 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: stopped early, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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?
The study was stopped early. Results are not available in the source record.
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?
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) (time frame: 1 year). 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 12 Feb 2014.