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Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization

NCT ID: NCT00841932

Last Updated: 2009-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fractional Flow Reserve

Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis

Fractional Flow Reserve

Intervention Type PROCEDURE

Fractional Flow Reserve performed without anticoagulation

Interventions

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Fractional Flow Reserve

Fractional Flow Reserve performed without anticoagulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria

* Therapeutic anticoagulation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Volcano Corporation

INDUSTRY

Sponsor Role collaborator

Clinyx, LLC

OTHER

Sponsor Role lead

Responsible Party

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Clinyx

Principal Investigators

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Jonathan Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

Clinyx, LLC

Other Identifiers

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CL-002

Identifier Type: -

Identifier Source: org_study_id

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