Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses (DEFINE-FLOW)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02328820 |
Recruitment Status :
Completed
First Posted : December 31, 2014
Last Update Posted : April 6, 2021
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Other: Percutaneous coronary intervention (PCI) Other: Optimal medical therapy (OMT) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 455 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | DEFINE-FLOW (Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect - Combined Pressure and Doppler FLOW Velocity Measurements) |
Actual Study Start Date : | October 2014 |
Actual Primary Completion Date : | November 2019 |
Actual Study Completion Date : | April 2021 |
Arm | Intervention/treatment |
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All patients
All lesions undergo simultaneous assessment with a combined pressure and flow sensor
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Other: Percutaneous coronary intervention (PCI)
For lesions with both FFR<=0.8 and CFR<2.0 Other: Optimal medical therapy (OMT) For lesions with FFR>0.8 or CFR>=2.0 or both |
- Major adverse cardiac events [ Time Frame: 24 months ]All-cause death, non-fatal myocardial infarction, urgent and elective revascularization
- Angina (Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina) [ Time Frame: 24 months ]Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years.
- Eligible for PCI based on local practice standards during the current procedure (PCI cannot be staged).
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At least one epicardial stenosis of ≥50% diameter (by visual or quantitative assessment) and meeting the following criteria as determined by the operator based on either a prior or the current diagnostic angiogram:
- <100% diameter (not a chronic, total occlusion);
- in a native coronary artery (including side branches but excludes bypass grafts);
- of ≥2.5mm reference diameter (near the level of the stenosis);
- and supplies sufficiently viable myocardium (exclude regions of known, prior, transmural myocardial infarction).
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
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Anatomic exclusions:
- Prior CABG.
- Preferred treatment strategy for revascularization would be CABG based on local practice standards.
- Left main coronary artery disease requiring revascularization.
- Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may also exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by ComboWire placement.
- Known severe LV hypertrophy (septal wall thickness at echocardiography of >13 mm).
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Clinical exclusions:
- Inability to receive intravenous adenosine (for example, severe reactive airway disease, marked hypotension, or high-grade AV block without pacemaker).
- Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
- Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included.
- Severe cardiomyopathy (LV ejection fraction <30%).
- Planned need for cardiac surgery (for example, valve surgery, treatment of aortic aneurysm, or septal myomectomy).
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General exclusions:
- A life expectancy of less than 2 years.
- Inability to sign an informed consent, due to any mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the trial or due to mental retardation or language barrier.
- Potential for non-compliance towards the requirements for follow-up visits.
- Participation or planned participation in another cardiovascular clinical trial before completing the 24 month follow-up.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328820
Denmark | |
Aarhus University Hospital | |
Aarhus, Denmark | |
Italy | |
Catholic University of the Sacred Heart | |
Rome, Italy | |
Japan | |
Gifu Heart Center | |
Gifu, Japan | |
Toda Central General Hospital | |
Toda, Japan | |
Tokyo Medical University | |
Tokyo, Japan | |
Tsuchiura Kyodo | |
Tsuchiura, Japan | |
Netherlands | |
Amsterdam UMC - location AMC | |
Amsterdam, Netherlands | |
Amsterdam UMC - location VUmc | |
Amsterdam, Netherlands | |
Tergooi Hospital | |
Blaricum, Netherlands | |
Amphia Hospital | |
Breda, Netherlands | |
Spain | |
Hospital Clinico San Carlos | |
Madrid, Spain | |
United Kingdom | |
Royal Free Hospital | |
London, United Kingdom |
Principal Investigator: | Nils Johnson, MD | University of Texas Medical School at Houston | |
Study Director: | Jan J Piek, MD, PhD | Academic Medical Center (AMC), Amsterdam |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Nils Johnson, Associate Professor of Medicine, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT02328820 |
Other Study ID Numbers: |
HSC-MS-14-0442 NL48375.018.14 ( Other Identifier: Academic Medical Center (AMC), University of Amsterdam ) |
First Posted: | December 31, 2014 Key Record Dates |
Last Update Posted: | April 6, 2021 |
Last Verified: | April 2021 |
Fractional Flow Reserve, Myocardial Coronary Flow Reserve |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |