Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease (FAVOR)
This study is currently recruiting participants.
Verified April 2013 by Ajou University School of Medicine
Sponsor:
Ajou University School of Medicine
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01175863
First received: August 3, 2010
Last updated: April 13, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Stenosis |
Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) Device: Pressure wire(Radi Medical Systems) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Fractional Flow Reserve- And Intra-vascular Ultrasound-Guided Percutaneous Coronary Intervention With Drug-Eluting Stents in Intermediate Coronary Artery Lesion (FAVOR Study) |
Resource links provided by NLM:
Further study details as provided by Ajou University School of Medicine:
Primary Outcome Measures:
- Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Cardiac death [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
- Myocardial infarction (MI) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
- Composite of cardiac death or myocardial infarction [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
- Target vessel revascularization (ischemia- and clinically-driven) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
- Target lesion revascularization (ischemia- and clinically-driven) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
- Stent thrombosis (Academic Research Consortium criteria) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
- In-stent and in-segment late loss on angiographic follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- In-stent and in-segment restenosis rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Incidence and angiographic pattern of restenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Canadian Cardiovascular Society Classification status [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
- The number of anti-angina medication [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
- Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
- Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Intravascular ultrasound |
Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)
minimal lumen area on Intravascular ultrasound
Other Names:
|
| Active Comparator: Fractional flow reserve |
Device: Pressure wire(Radi Medical Systems)
Fractional flow reserve measured by pressure wire
Other Name: Pressure wire (Radi Medical Systems)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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 %)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175863
Contacts
| Contact: Seung-Jea Tahk, MD, PhD | +82 31 219 5712 | sjtahk@ajou.ac.kr |
| Contact: Hyoung-Mo Yang, MD | +82 31 219 5712 | yhhm20@hanmail.net |
Locations
| Korea, Republic of | |
| Keimyung university Dongsan medical center | Recruiting |
| Daegu, Korea, Republic of | |
| Principal Investigator: Seung-Ho Hur, MD | |
| Inje University | Recruiting |
| Ilsan, Korea, Republic of | |
| Principal Investigator: Jun-Hyung Do, MD | |
| Seoul national university hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Principal Investigator: Bon-Kwon Koo, MD, PhD | |
| Yensei University Gangnam Severance Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Principal Investigator: Pil-Ki Min, MD | |
| Seoul National University Boramae Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Principal Investigator: Woo-Young Chung, MD | |
| Korea University Guro Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Principal Investigator: Seung-Woon Rha, MD | |
| Ajou University Medical Center | Recruiting |
| Suwon, Korea, Republic of | |
| Principal Investigator: Seung-Jea Tahk, MD, PhD | |
| Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital | Recruiting |
| Wonju, Korea, Republic of | |
| Principal Investigator: Jung Han Yoon, MD | |
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
| Principal Investigator: | Sejung-Jea Tahk, MD, PhD | Ajou University Medical Center, Ajou University School of Medicine |
More Information
No publications provided
| Responsible Party: | Seung-Jea Tahk, MD, Ajou University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01175863 History of Changes |
| Other Study ID Numbers: | FAVOR |
| Study First Received: | August 3, 2010 |
| Last Updated: | April 13, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Ajou University School of Medicine:
|
intravascular ultrasound fractional flow reserve |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Coronary Stenosis Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013