Fenestrated Endovascular Aortic RepairNCT02266862
Changes in Renal Artery Movement Due to Respiration Before and After Fenestrated Endovascular Repair
An observational study of Fenestrated Endovascular Aortic Repair, run by University of North Carolina, Chapel Hill.
Trial summary
Purpose: The purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fenestrated Endovascular Aortic Repair
- What is being tested?
- Study group
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2015
- 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 with fenestrated endovascular aortic repair (FEVAR) will be included in this study.
Who may be able to join
- Undergoing pre-procedural CT scan for FEVAR
Who cannot join
- Has aortic/renal stent already
- Cannot receive IV contrast due to renal insufficiency or allergy
- Renal arteries are not patent
About this study
Purpose: The purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. Then, the renal artery segment with maximal angular displacement on each will be located and any changes described.
Participants: There will be 30 subjects recruited from UNC Hospitals.
Procedures (methods): For this study, patients will receive an additional CT sequence (end-expiration CT), which will be compared with the standard of care end-inspiration CT to calculate angular displacement and the distance from the aorta.
Read the detailed description
The investigators would like to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. The investigators would then locate the renal artery segment with maximal angular displacement on each and describe any changes. Because these patients would be getting pre and post-surgical CTs as part of standard of care, there would be no added charge to obtain the information for the study. There would be, however, minimal increased radiation exposure resulting from the extra scan being performed during end-expiration and the patients would have to consent to the slight added risk to participate.
- Conditions
- Fenestrated Endovascular Aortic Repair
- Being tested
- Study group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study groupRadiation
Patients will receive an additional CT sequence (end-expiration) at the time of their standard CT imaging before and after the repair.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. Receives: Radiation: Study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in angular displacement
We will calculate the distance from the aorta and angular displacement both before and after the procedure. Then, a paired t-test will be used to compare these values to determine statistical significance.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fenestrated Endovascular Aortic RepairStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ari Isaacson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266862
- Sponsor's protocol ID
- 14-2330
- Status last verified
- May 2017
- First submitted
- 13 Oct 2014
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Renal Artery Movement Due to Respiration Before and After Fenestrated Endovascular Repair
- ClinicalTrials.gov ID
- NCT02266862
- Acronym / sponsor ID
- 14-2330
- Conditions
- Fenestrated Endovascular Aortic Repair
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Oct 2014 (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.
Purpose: The purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. Then, the renal artery segment with maximal angular displacement on each will be located and any changes described.
Participants: There will be 30 subjects recruited from UNC Hospitals.
Procedures (methods): For this study, patients will receive an additional CT sequence (end-expiration CT), which will be compared with the standard of care end-inspiration CT to calculate angular displacement and the distance from the aorta.
Detailed description
The investigators would like to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. The investigators would then locate the renal artery segment with maximal angular displacement on each and describe any changes. Because these patients would be getting pre and post-surgical CTs as part of standard of care, there would be no added charge to obtain the information for the study. There would be, however, minimal increased radiation exposure resulting from the extra scan being performed during end-expiration and the patients would have to consent to the slight added risk to participate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Radiation: Study groupThe purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fenestrated endovascular aortic repair (FEVAR) will be included in this study.
Key inclusion criteria (1 listed)
- Undergoing pre-procedural CT scan for FEVAR
Key exclusion criteria (3 listed)
- Has aortic/renal stent already
- Cannot receive IV contrast due to renal insufficiency or allergy
- Renal arteries are not patent
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 |
|---|---|---|
| Study groupPatients will receive an additional CT sequence (end-expiration) at the time of their standard CT imaging before and after the repair. | Radiation | Study Group |
Primary outcome
Change in angular displacement
Time frame: Baseline, 6 months
We will calculate the distance from the aorta and angular displacement both before and after the procedure. Then, a paired t-test will be used to compare these values to determine statistical significance.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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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.
Ari Isaacson, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
An observational study of Fenestrated Endovascular Aortic Repair, run by University of North Carolina, Chapel Hill.
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 3 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: withdrawn, as of the sponsor's last update on 5 Jun 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in angular displacement (time frame: Baseline, 6 months). 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 5 Jun 2017.