Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion criteria

Therapeutic anticoagulation

Treatment and study plan

Fractional flow reserve

Procedure

Fractional Flow Reserve performed without anticoagulation

Primary outcomes

Complications related to use of pressure wire

Time frame: 0-30 days (index procedure)

Secondary outcomes

Complications due to FFR procedure

Time frame: 0-30 days (index hospitalization)

Sponsors and collaborators

Lead sponsor

Clinyx, LLC

Other

Collaborators

Volcano Corporation

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Feb 12, 2009
Registry last updated: Feb 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed