Routine Versus Selective Use of FFR to Guide PCI

NCT02000661 | Terminated Phase 4

• 1 other identifier: H13-02709
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 4

Brief Summary

Fractional flow reserve (FFR) is a test that can be performed at the time of heart catheterization. It measures the change in pressure across a narrowing in the heart artery during high flow situation, and provides reliable information about the functional severity of the narrowing. FFR measurements accurately predict whether a stent is needed, and is considered an excellent test before placement of stents to treat narrowed heart arteries. However, FFR is not used in every case because of the extra time needed and the associated device costs. Cardiac Services BC (an agency of Provincial Health Services Authority) is sponsoring this study to find out if FFR should be used in most cases (routine), rather than the current selective approach.

Conditions

Acute Coronary Syndrome; Coronary Atherosclerosis; Angina, Unstable

Keywords

Fractional Flow Reserve (FFR); FFR guided coronary interventions; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Composite of all cause mortality, repeat hospitalization for MI or repeat revascularization (PCI or coronary artery bypass grafting - CABG)

  1 Year

Secondary Outcomes (4)

• All cause mortality

  1 Year

• Repeat hospitalization for MI

  1 Year

• Rate of repeat revascularization (PCI or CABG)

  1 Year

• Time of procedure, contrast amount, and radiation dose

  Post-procedure

Other Outcomes (1)

• Economic evaluation, including health resource utilization

  1 Year

Study Arms (2)

Routine use of FFR

EXPERIMENTAL

Fractional Flow Reserve (FFR) used in most cases to guide PCI

Device: Fractional Flow Reserve (FFR)

Selective use of FFR

ACTIVE COMPARATOR

Fractional Flow Reserve (FFR) used at investigator discretion (Current practice)

Device: Fractional Flow Reserve (FFR)

Interventions

Fractional Flow Reserve (FFR) DEVICE

Fractional Flow Reserve (FFR) performed per guidelines to guide PCI

Also known as: FFR Wire (PressureWire™ by St. Jude Medical)

Routine use of FFR; Selective use of FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with stable coronary artery disease or recent acute coronary syndrome (ACS). Subjects who present with ST elevation myocardial infarction (STEMI) are allowed to be included after 5 days from initial presentation.
• At least one obstructive coronary lesion is present with vessel reference diameter ≥2.5 mm and diameter stenosis ≥50% by visual estimate. Lesions must be technically suitable for the FFR procedure and angioplasty with stent placement.
• Physician will classify all target lesions and need for FFR before randomization, and there is a plan to perform a non-emergent PCI.
• Subject is ≥18 years old, with signed informed consent.

You may not qualify if:

• Expected non-cardiac longevity \< 2 years.
• Planned treatment with CABG.
• Planned treatment with medical therapy.
• Left main disease \> 50% diameter stenosis based on visual estimate.
• Safety issues:
• Unstable hemodynamics or serious arrhythmias during procedure;
• Ongoing ischemic chest pain;
• High grade AV block (unless pacemaker);
• Allergic to adenosine.
• When FFR is clearly not needed:
• Target vessel with slow flow (\< TIMI-3);
• Single vessel disease with ≥90% stenosis;
• Single vessel disease with ≥80% stenosis and documented ischemia on functional imaging test;
• In acute coronary syndrome, ≥70 stenosis identified as culprit.
• When FFR is clearly needed for all target lesions: as declared by the operator.

Sponsors & Collaborators

• Cardiology Research UBC: lead
• Provincial Health Services Authority British Columbia: collaborator

Study Sites (4)

Kelowna General Hospital

Kelowna, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Fung, MBBS, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 4, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

CA (4)