Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses (DEFINE-FLOW)
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ClinicalTrials.gov Identifier: NCT02328820 |
Recruitment Status :
Completed
First Posted : December 31, 2014
Last Update Posted : April 6, 2021
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Sponsor:
The University of Texas Health Science Center, Houston
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Volcano Corporation
Information provided by (Responsible Party):
Nils Johnson, The University of Texas Health Science Center, Houston
Tracking Information | |||||||
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First Submitted Date ICMJE | December 18, 2014 | ||||||
First Posted Date ICMJE | December 31, 2014 | ||||||
Last Update Posted Date | April 6, 2021 | ||||||
Actual Study Start Date ICMJE | October 2014 | ||||||
Actual Primary Completion Date | November 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Major adverse cardiac events [ Time Frame: 24 months ] All-cause death, non-fatal myocardial infarction, urgent and elective revascularization
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses | ||||||
Official Title ICMJE | DEFINE-FLOW (Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect - Combined Pressure and Doppler FLOW Velocity Measurements) | ||||||
Brief Summary | This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI). | ||||||
Detailed Description | Pressure and flow represent the two physiologic variables that can be measured directly inside a coronary artery. Already pressure measurements have proven their clinical value in the form of fractional flow reserve (FFR). However, myocardial function can remain intact with sufficient flow, even at a low perfusion pressure. Therefore, combined pressure and flow measurements provide a more complete description of physiologic stenosis severity as a guide to medical treatment versus revascularization. Based on existing work relating the most common flow measurement, coronary flow reserve (CFR), to FFR and linking both variables with subsequent prognosis, we hypothesize that lesions with an intact CFR>=2.0 can be reasonably treated with medical therapy despite a reduced FFR<=0.8. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Coronary Artery Disease | ||||||
Intervention ICMJE |
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Study Arms ICMJE | All patients
All lesions undergo simultaneous assessment with a combined pressure and flow sensor
Interventions:
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
455 | ||||||
Original Estimated Enrollment ICMJE |
500 | ||||||
Actual Study Completion Date ICMJE | April 2021 | ||||||
Actual Primary Completion Date | November 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Denmark, Italy, Japan, Netherlands, Spain, United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02328820 | ||||||
Other Study ID Numbers ICMJE | HSC-MS-14-0442 NL48375.018.14 ( Other Identifier: Academic Medical Center (AMC), University of Amsterdam ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Nils Johnson, The University of Texas Health Science Center, Houston | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | The University of Texas Health Science Center, Houston | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |