Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy (FIRST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Volcano Corporation
ClinicalTrials.gov Identifier:
NCT01153555
First received: June 28, 2010
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

This is a multi-center, prospective registry of patients with intermediate coronary lesions defined as a stenosis of 40-80% by angiography. Approximately 300 patients will be enrolled into the study at sites in the United States and Europe. There will be no follow up beyond hospital discharge in this study. A sub-group of 30 patients will undergo Adenosine MRI. The investigators hypothesize that Intravascular Ultrasound Radiofrequency (IVUS RF) anatomical criteria, such as minimal luminal area, plaque burden and virtual histology plaque type, can predict physiological ischemia by Fractional Flow Reserve (FFR).


Condition Intervention
Coronary Artery Disease
Device: FFR and IVUS RF
Device: FFR and IVUS RF and MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy: The FIRST Study

Resource links provided by NLM:


Further study details as provided by Volcano Corporation:

Primary Outcome Measures:
  • Correlation between (Minimum Luminal Area) MLA and FFR [ Time Frame: Day of Procedure ] [ Designated as safety issue: No ]
    The correlation between MLA and FFR; and the threshold value for MLA corresponding to an FFR < 0.8.


Secondary Outcome Measures:
  • Correlation between FFR and IVUS and VH parameters [ Time Frame: Day of Procedure ] [ Designated as safety issue: No ]
    Correlation between FFR and various IVUS measurements (MLA,area stenosis, lesion length, plaque burden) and VH parameters (plaque type and presence of a TCFA)

  • Association of FFR and Cut-off of MLA [ Time Frame: Day of Procedure ] [ Designated as safety issue: No ]
    Assess the association between FFR <0.75 and 0.8 and determined cut-off of MLA with presence of a Thin Cap Fibro-Atheroma(TCFA) and/or plaque burden ≥70%

  • Identify risk score model [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To identify a risk score model taking into account IVUS measurements (MLA, plaque burden, area stenosis, lesion length) and VH parameters (plaque type and presence of TCFA) associated with FFR < 0.8


Enrollment: 300
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No revascularization planned
Up to 30 patients enrolled at Washington Hospital Center with intermediate lesions (FFR>0.8) and revascularization planned will undergo an Adenosine Cardiac MRI subsequent to the angiography for validation of the FFR specificity.
Device: FFR and IVUS RF and MRI
  • Patient meets all inclusion and none of exclusion criteria
  • Patient is enrolled at Washington Hospital Center
  • FFR is interrogated and the IVUS RF
  • FFR is negative and no revascularization
  • Patient will be evaluated by Adenosine MRI to determine specificity of FFR
All procedures
Patients who have meet the inclusion criteria and none of the exclusion criteria, including the angiographic criteria, will be eligible for enrollment into the FIRST trial. Once a lesion has been identified the lesions will be first interrogated with FFR followed by IVUS RF evaluation. The IVUS RF run should start a minimum of 5 mm distal to the FFR wire placement and continue proximally for 5 mm proximal to the lesion.
Device: FFR and IVUS RF
  • Patient mets inclusion criteria and none of exclusion criteria
  • Once lesion is identified, FFR will be interrogated and then followed by IVUS RD evaluation
  • PCI will be pursued if Investigator deems necessary

Detailed Description:

Patients undergoing cardiac catheterization must meet clinical inclusion and exclusion criteria and sign an informed consent. At the time of catheterization the patients will be further analyzed for eligibility using angiographic inclusion and exclusion criteria. Patients who fulfilled the clinical and angiographic criteria will undergo further imaging evaluation using an IVUS RF catheter (Volcano Therapeutics) and FFR wire (Radi or Volcano). The decision for treatment of any lesion will be at the operator's discretion. For patients enrolled at Washington Hospital Center and do not undergo percutaneous coronary intervention, an assessment with non invasive perfusion adenosine MRI also be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign written informed consent to participate in the study.
  • Clinical indication for coronary angiography for stable or unstable angina

Specific Angiographic Inclusion Criteria:

  • Patients required to have an intermediate coronary lesion (stenosis 40-80% by visual estimate) in one or more native, major epicardial coronary artery with reference diameter ≥2.5mm (visual estimate)
  • The vessel(s) with the intermediate lesion must have no flow limiting lesions and must be available for imaging and must be considered safe for imaging evaluation.

Exclusion Criteria:

  • Patient has had a documented acute ST-segment elevation myocardial infarction within the past 24 hours
  • Decompensated heart failure or hypotension requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation.
  • Renal dysfunction (creatinine clearance < 60 mL/min/1.73m2)
  • Pregnancy or breast-feeding
  • Standard contra-indications to MRI for implanted ferro-magnetic devices - i.e.: pacemakers, defibrillator (AICD), and aneurysm clips
  • Body weight > 400lbs
  • Left ventricular hypertrophy >1.5cm by by echocardiogram
  • History of bronchospasm or asthma
  • ECG evidence of conduction defect, including 2nd or 3rd degree AVB
  • Patient has a known hypersensitivity, allergy or contraindication to gadolinium-based contrast agents.
  • Prior participation in this study or patient is currently enrolled in another investigational use device or drug study that has not reached its primary endpoint. If the patient is enrolled in another study that is not investigational, required visits for that trial must not interfere with the conduct of this trial.

Angiographic Exclusion Criteria:

  • Unprotected left main lesion location.
  • Ostial lesion
  • Angiographic evidence of severe calcification or marked tortuosity of the target vessel that would preclude safe imaging
  • Lesion is located within or distal to an arterial or saphenous vein graft.
  • Angiographic presence of thrombus in the lesion or vessel studied.
  • Lesion in a vessel with <2.5 mm reference diameter or with more than one lesion in the vessel
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153555

Sponsors and Collaborators
Volcano Corporation
Investigators
Principal Investigator: Ron Waksman, MD Washington Hospital Center
  More Information

No publications provided

Responsible Party: Volcano Corporation
ClinicalTrials.gov Identifier: NCT01153555     History of Changes
Other Study ID Numbers: FIRST
Study First Received: June 28, 2010
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014