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PRESSUREwire Study

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ClinicalTrials.gov Identifier: NCT02935088
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

Condition or disease Intervention/treatment
Coronary Artery Disease Acute Coronary Syndrome Device: Fractional Flow Reserve

Detailed Description:

The purpose of this study is to understand routine use of FFR and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

The study will also collect data on the routine use of coronary physiologic measurements such as adenosine-induced hyperemia FFR, FFR by contrast-induced hyperemia,


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Study Type : Observational
Actual Enrollment : 2217 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Practical Evaluation of Fractional Flow Reserve (FFR) and Its Associated Alternate Indices During Routine Clinical Procedures
Actual Study Start Date : October 12, 2016
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : March 22, 2019

Intervention Details:
  • Device: Fractional Flow Reserve
    Measurement of physiologic parameters
    Other Name: PressureWire


Primary Outcome Measures :
  1. Characterize the 12 month clinical outcomes (MACE) Major Adverse Cardiac Event by FFR values and resting indices [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Compare resting indices with FFR values [ Time Frame: at time of procedure ]
  2. Characterize the frequency of change in treatment plan when FFR is used compared to the initial decision based on angiography alone [ Time Frame: at time of procedure ]
  3. Characterize the 12 month clinical outcomes (MACE) in subjects in whom the use of FFR did not lead to a change in treatment decision vs subjects in whom the use of FFR led to a change in treatment decision [ Time Frame: 12 months ]
  4. Characterize the 12 month clinical outcomes (MACE) by other PressureWire-derived indices (coronary flow reserve (CFR), index of microcirculatory resistance (IMR), contrast FFR, resistance reserve ratio (RRR)). [ Time Frame: 12 months ]
  5. Compare other PressureWire-derived indices (CFR, IMR, contrast FFR, RRR) with FFR values [ Time Frame: at time of procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients where FFR has been performed or is planned to be performed for further evaluation of PCI procedures, as per physician clinical practice.
Criteria

Inclusion Criteria:

  • Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease
  • Patient is planned to have FFR performed or underwent a cardiac catheterization where FFR was performed for further PCI (Percutaneous Cardiac Intervention) consideration
  • Patient signs and dates written informed consent
  • Patient is eighteen years of age or older at the time of consent

Exclusion Criteria:

  • Patient has extremely tortuous or calcified coronary arteries
  • Patient with a patent coronary artery bypass graft to the target vessel

Information from the National Library of Medicine

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): NCT02935088


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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Colin Berry, MD University of Glasgow

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02935088     History of Changes
Other Study ID Numbers: SJM-CIP-10136
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
FFR
Percutaneous coronary intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases