Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Fractional Flow Reserve

• Registration Number: NCT00841932
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-02
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-11
• Last Update Submitted: 2009-02-11
• Study First Posted: 2009-02-12
• Last Update Posted: 2009-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria

• Therapeutic anticoagulation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fractional Flow Reserve	Fractional Flow Reserve	Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis

Primary Outcome Measures

Name	Time	Method
Complications related to use of pressure wire	0-30 days (index procedure)

Secondary Outcome Measures

Name	Time	Method
Complications due to FFR procedure	0-30 days (index hospitalization)