Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization

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. Identifier: NCT00841932
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : February 12, 2009
Volcano Corporation
Information provided by:
Clinyx, LLC

Brief Summary:
The purpose of this study is to assess the safety of performing fractional flow reserve (FFR) of the myocardium without using anticoagulation by performing a retrospective review of 100 consecutive patients who have undergone this procedure during diagnostic catheterization.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Fractional Flow Reserve

Detailed Description:
An experienced interventional cardiologist can perform FFR in a brief period of time. This procedure can safely be performed without anticoagulation, thereby lowering the associated procedural risks by avoiding the bleeding and groin complications that may occur with anticoagulation. Performing FFR without anticoagulation may also decrease facility costs as femoral artery closure can be performed using standard protocols for a diagnostic procedure, instead of standard protocols for an interventional procedure when a patient has been anticoagulated. Performing FFR without anticoagulation does not increase risk of injury to the coronary artery or thrombus in the coronary artery.

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization
Study Start Date : August 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Group/Cohort Intervention/treatment
Fractional Flow Reserve
Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis
Procedure: Fractional Flow Reserve
Fractional Flow Reserve performed without anticoagulation

Primary Outcome Measures :
  1. Complications related to use of pressure wire [ Time Frame: 0-30 days (index procedure) ]

Secondary Outcome Measures :
  1. Complications due to FFR procedure [ Time Frame: 0-30 days (index hospitalization) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.

Inclusion Criteria:

  • Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria:

  • Therapeutic anticoagulation

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 identifier (NCT number): NCT00841932

Sponsors and Collaborators
Clinyx, LLC
Volcano Corporation
Principal Investigator: Jonathan Roberts, MD Clinyx, LLC

Responsible Party: Holly Taylor, VP, Clinyx Identifier: NCT00841932     History of Changes
Other Study ID Numbers: CL-002
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009

Keywords provided by Clinyx, LLC:
Fractional Flow Reserve
Without anticoagulation

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