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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00841932
Enrollment
100
Registered
2009-02-12
Start date
2008-08-31
Completion date
2008-10-31
Last updated
2009-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Fractional Flow Reserve, Without anticoagulation

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.

Interventions

PROCEDUREFractional Flow Reserve

Fractional Flow Reserve performed without anticoagulation

Sponsors

Volcano Corporation
CollaboratorINDUSTRY
Clinyx, LLC
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion criteria

* Therapeutic anticoagulation

Design outcomes

Primary

MeasureTime frame
Complications related to use of pressure wire0-30 days (index procedure)

Secondary

MeasureTime frame
Complications due to FFR procedure0-30 days (index hospitalization)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026