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Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization

This study has been completed.
Sponsor:
Collaborator:
Volcano Corporation
Information provided by:
Clinyx, LLC
ClinicalTrials.gov Identifier:
NCT00841932
First received: February 6, 2009
Last updated: February 11, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Procedure: Fractional Flow Reserve

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clinyx, LLC:

Primary Outcome Measures:
  • Complications related to use of pressure wire [ Time Frame: 0-30 days (index procedure) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complications due to FFR procedure [ Time Frame: 0-30 days (index hospitalization) ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fractional Flow Reserve
Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis
 Procedure: Fractional Flow Reserve
Fractional Flow Reserve performed without anticoagulation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.

Criteria

Inclusion Criteria:

  • Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria:

  • Therapeutic anticoagulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841932

Sponsors and Collaborators
Clinyx, LLC
Volcano Corporation
Investigators
Principal Investigator: Jonathan Roberts, MD Clinyx, LLC
  More Information

No publications provided

Responsible Party: Holly Taylor, VP, Clinyx
ClinicalTrials.gov Identifier: NCT00841932     History of Changes
Other Study ID Numbers: CL-002
Study First Received: February 6, 2009
Last Updated: February 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Clinyx, LLC:
Fractional Flow Reserve
Without anticoagulation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013