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Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses (DEFINE-FLOW)

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 : Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : January 17, 2019
Sponsor:
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
First Submitted Date  ICMJE December 18, 2014
First Posted Date  ICMJE December 31, 2014
Last Update Posted Date January 17, 2019
Actual Study Start Date  ICMJE October 2014
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
Major adverse cardiac events [ Time Frame: 24 months ]
All-cause death, non-fatal myocardial infarction, urgent and elective revascularization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
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)
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 Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE All patients
All lesions undergo simultaneous assessment with a combined pressure and flow sensor
Interventions:
  • Other: Percutaneous coronary intervention (PCI)
  • Other: Optimal medical therapy (OMT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 15, 2019)
455
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2014)
500
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years.
  • Eligible for PCI based on local practice standards during the current procedure (PCI cannot be staged).
  • 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:

  • 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).
  • 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).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nils Johnson, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Volcano Corporation
Investigators  ICMJE
Principal Investigator: Nils Johnson, MD University of Texas Medical School at Houston
Study Director: Jan J Piek, MD, PhD Academic Medical Center (AMC), Amsterdam
PRS Account The University of Texas Health Science Center, Houston
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP