Coronary Artery DiseaseNCT00841932
Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization
An observational study of Coronary Artery Disease, run by Clinyx, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Fractional Flow Reserve
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.
Who may be able to join
- Patients with moderate stenosis who underwent FFR without anticoagulation
Who cannot join
- Therapeutic anticoagulation
About this study
Official title: Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Fractional Flow Reserve
- Keywords
- Fractional Flow Reserve, Without anticoagulation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Flow ReserveProcedure or surgery
Fractional Flow Reserve performed without anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Fractional Flow Reserve | Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis Receives: Procedure: Fractional Flow Reserve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications related to use of pressure wire
Measured: 0-30 days (index procedure)
Secondary outcomes (1)
Complications due to FFR procedure
Measured: 0-30 days (index hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinyx, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Volcano Corporation
- Investigators
- Jonathan Roberts, MD, Principal investigator, Clinyx, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841932
- Sponsor's protocol ID
- CL-002
- Status last verified
- Feb 2009
- First submitted
- 6 Feb 2009
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT00841932
- Acronym / sponsor ID
- CL-002
- Conditions
- Coronary Artery Disease
- Keywords
- Fractional Flow Reserve, Without anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinyx, LLCUniversity, hospital or other
- Collaborators
- Volcano Corporation
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional Flow Reserve | – | Procedure: Fractional Flow ReservePatients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.
Key inclusion criteria (1 listed)
- Patients with moderate stenosis who underwent FFR without anticoagulation
Key exclusion criteria (1 listed)
- Therapeutic anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional Flow ReserveFractional Flow Reserve performed without anticoagulation | Procedure or surgery | Fractional Flow Reserve |
Primary outcome
Complications related to use of pressure wire
Time frame: 0-30 days (index procedure)
1 secondary outcome
Complications due to FFR procedure
Time frame: 0-30 days (index hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Roberts, MD principal investigator
Clinyx, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Clinyx, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications related to use of pressure wire (time frame: 0-30 days (index procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2009.