Aortic AneurysmSAFRANENCT04909190
Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
A study testing Increased saline flush volume in people with Aortic Aneurysm and Aortic Aneurysm, Thoracic, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Aneurysm, Thoracic, Aortic Diseases
- What is being tested?
- Increased saline flush volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 10 Jun 2021to 30 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal
Who cannot join
- concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.
- Being tested
- Increased saline flush volume
- Keywords
- endovascular, evar, tevar, stentgraft, de-airing
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Thoracic, Aortic Diseases, Aneurysm, Aortic Arch, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased saline flush volumeProcedure or surgery
Additional flushing of the stentgraft delivery system.
| Study group | Role | What they receive |
|---|---|---|
| 1xIFU | No intervention | Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device. |
| 4xIFU | Experimental | Subjects in this arm are randomized to have a saline flush volume of 4x of what is stated in the IFU of the used device. Receives: Procedure: Increased saline flush volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air volume
Total volume of air inside the aneurysm sac on discharge CT imaging.
Measured: within 7 days after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start10 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Csaba Csobay-Novák MD PhD, Semmelweis University Heart and Vascular Center
- Investigators
- Csaba Csobay-Novák, MD PhD, Study director, Dept. of Interventional Radiology, Heart and Vascular Center, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909190
- Sponsor's protocol ID
- SF2021
- Acronym
- SAFRANE
- Status last verified
- Jul 2022
- First submitted
- 26 May 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szentivanyi A, Borzsak S, Vecsey-Nagy M, Suvegh A, Huttl A, Fontanini DM, Szeberin Z, Csobay-Novak C. The impact of increasing saline flush volume to reduce the amount of residual air in the delivery system of aortic prostheses-a randomized controlled trial. Front Cardiovasc Med. 2024 Mar 22;11:1335903. doi: 10.3389/fcvm.2024.1335903. eCollection 2024.
PubMed 38586170
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
- ClinicalTrials.gov ID
- NCT04909190
- Acronym / sponsor ID
- SAFRANE / SF2021
- Keywords
- endovascular, evar, tevar, stentgraft, de-airing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 Jun 2021 (actual)
- 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.
Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1xIFU | No intervention | –Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device. |
| 4xIFU | Experimental | Procedure: Increased saline flush volumeSubjects in this arm are randomized to have a saline flush volume of 4x of what is stated in the IFU of the used device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal
Key exclusion criteria (1 listed)
- concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side
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 |
|---|---|---|
| Increased saline flush volumeAdditional flushing of the stentgraft delivery system. | Procedure or surgery | 4xIFU |
Primary outcome
Air volume
Time frame: within 7 days after index procedure
Total volume of air inside the aneurysm sac on discharge CT imaging.
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 20 Jul 2022.
- Derived from this study: PubMed 38586170Szentivanyi A, Borzsak S, Vecsey-Nagy M, Suvegh A, Huttl A, Fontanini DM, Szeberin Z, Csobay-Novak C. The impact of increasing saline flush volume to reduce the amount of residual air in the delivery system of aortic prostheses-a randomized controlled trial. Front Cardiovasc Med. 2024 Mar 22;11:1335903. doi: 10.3389/fcvm.2024.1335903. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Csaba Csobay-Novák, MD PhD study director
Dept. of Interventional Radiology, Heart and Vascular Center, Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased saline flush volume in people with Aortic Aneurysm and Aortic Aneurysm, Thoracic, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Air volume (time frame: within 7 days after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909190, which also lists 1 linked publication.
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 20 Jul 2022.