Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization

This study has been completed.
Sponsor:
Collaborator:
Volcano Corporation
Information provided by:
Clinyx, LLC
ClinicalTrials.gov Identifier:
NCT00841932
First received: February 6, 2009
Last updated: February 11, 2009
Last verified: February 2009

February 6, 2009
February 11, 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) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00841932 on ClinicalTrials.gov Archive Site
Complications due to FFR procedure [ Time Frame: 0-30 days (index hospitalization) ] [ Designated as safety issue: Yes ]
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
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00841932
CL-002
No
Holly Taylor, VP, Clinyx
Clinyx, LLC
Volcano Corporation
Principal Investigator: Jonathan Roberts, MD Clinyx, LLC
Clinyx, LLC
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP