Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PRESSUREwire Study

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: NCT02935088
Recruitment Status : Completed
First Posted : October 17, 2016
Results First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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,

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices [ Time Frame: 12 months ]

    Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization.

    Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR ≤ 0.8) and high FFR group (FFR > 0.8).



Other Outcome Measures:
  1. Correlation of Resting Indices With FFR Values [ Time Frame: at time of procedure ]
    Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices.

  2. Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone [ Time Frame: at time of procedure ]
    Treatment decision was defined as "changed" if there is at least one decision change based on FFR for multiple lesions; if none of the decisions was changed for the multiple lesions, the treatment decision is defined as "unchanged".

  3. Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up 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 ]
    Number of subjects with 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up 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.

  4. Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) [ Time Frame: 12 months ]

    Number of subjects with 12-month clinical outcomes (MACE) by other PressureWire-derived indices (contrast FFR).

    Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization.


  5. Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values [ Time Frame: at time of procedure ]
    Linear correlation of FFR and contrast FFR (cFFR). Only subjects that had both FFR and cFFR were used in the analysis.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 71 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Colin Berry, MD University of Glasgow
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol and Statistical Analysis Plan  [PDF] August 1, 2016

More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02935088    
Other Study ID Numbers: SJM-CIP-10136
First Posted: October 17, 2016    Key Record Dates
Results First Posted: February 7, 2020
Last Update Posted: February 7, 2020
Last Verified: January 2020
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:
Layout table for MeSH terms
Coronary Artery Disease
Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases