Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization
| Tracking Information | |||||
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| First Received Date ICMJE | February 6, 2009 | ||||
| Last Updated Date | February 11, 2009 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Complications related to use of pressure wire [ Time Frame: 0-30 days (index procedure) ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00841932 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Complications due to FFR procedure [ Time Frame: 0-30 days (index hospitalization) ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization | ||||
| Official Title ICMJE | Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Procedure: Fractional Flow Reserve
Fractional Flow Reserve performed without anticoagulation |
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| Study Group/Cohort (s) | Fractional Flow Reserve
Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis
Intervention: Procedure: Fractional Flow Reserve |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00841932 | ||||
| Other Study ID Numbers ICMJE | CL-002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Holly Taylor, VP, Clinyx | ||||
| Study Sponsor ICMJE | Clinyx, LLC | ||||
| Collaborators ICMJE | Volcano Corporation | ||||
| Investigators ICMJE |
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| Information Provided By | Clinyx, LLC | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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