Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841932
• Other study ID #: CL-002
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: February 11, 2009
• Start date: August 2008
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: Clinyx, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria:

• Therapeutic anticoagulation

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Fractional Flow Reserve
Fractional Flow Reserve performed without anticoagulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clinyx, LLC	Volcano Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications related to use of pressure wire		0-30 days (index procedure)	Yes
Secondary	Complications due to FFR procedure		0-30 days (index hospitalization)	Yes