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Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00841932
First Posted: February 12, 2009
Last Update Posted: February 12, 2009
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.
Collaborator:
Volcano Corporation
Information provided by:
Clinyx, LLC
February 6, 2009
February 12, 2009
February 12, 2009
August 2008
October 2008   (Final data collection date for primary outcome measure)
Complications related to use of pressure wire [ Time Frame: 0-30 days (index procedure) ]
Same as current
No Changes Posted
Complications due to FFR procedure [ Time Frame: 0-30 days (index hospitalization) ]
Same as current
Not Provided
Not Provided
 
Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization
Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.
Coronary Artery Disease
Procedure: Fractional Flow Reserve
Fractional Flow Reserve performed without anticoagulation
Fractional Flow Reserve
Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis
Intervention: Procedure: Fractional Flow Reserve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria:

  • Therapeutic anticoagulation
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00841932
CL-002
No
Not Provided
Not Provided
Holly Taylor, VP, Clinyx
Clinyx, LLC
Volcano Corporation
Principal Investigator: Jonathan Roberts, MD Clinyx, LLC
Clinyx, LLC
February 2009