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

April 5, 2021 updated by: Nils Johnson, The University of Texas Health Science Center, Houston

DEFINE-FLOW (Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect - Combined Pressure and Doppler FLOW Velocity Measurements)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

455

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
  • Italy
      • Rome, Italy
        • Catholic University of the Sacred Heart
  • Japan
      • Gifu, Japan
        • Gifu Heart Center
      • Toda, Japan
        • Toda Central General Hospital
      • Tokyo, Japan
        • Tokyo Medical University
      • Tsuchiura, Japan
        • Tsuchiura Kyodo
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC - Location AMC
      • Amsterdam, Netherlands
        • Amsterdam UMC - location VUMC
      • Blaricum, Netherlands
        • Tergooi Hospital
      • Breda, Netherlands
        • Amphia Hospital
  • Spain
      • Madrid, Spain
        • Hospital Clinico San Carlos
  • United Kingdom
      • London, United Kingdom
        • Royal Free Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All patients
All lesions undergo simultaneous assessment with a combined pressure and flow sensor
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events
Time Frame: 24 months
All-cause death, non-fatal myocardial infarction, urgent and elective revascularization
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Volcano Corporation

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-14-0442
  • NL48375.018.14 (Other Identifier: Academic Medical Center (AMC), University of Amsterdam)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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