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Clinical Trials/NCT00841932
NCT00841932
Completed
Not Applicable

Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization

Clinyx, LLC0 sites100 target enrollmentAugust 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Clinyx, LLC
Enrollment
100
Primary Endpoint
Complications related to use of pressure wire
Status
Completed
Last Updated
17 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
October 2008
Last Updated
17 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Clinyx, LLC

Eligibility Criteria

Inclusion Criteria

  • Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria

  • Therapeutic anticoagulation

Outcomes

Primary Outcomes

Complications related to use of pressure wire

Time Frame: 0-30 days (index procedure)

Secondary Outcomes

  • Complications due to FFR procedure(0-30 days (index hospitalization))

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