Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
SAFRANE
A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJuly 20, 2022
July 1, 2022
1.1 years
May 26, 2021
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Air volume
Total volume of air inside the aneurysm sac on discharge CT imaging.
within 7 days after index procedure
Study Arms (2)
1xIFU
NO INTERVENTIONSubjects in this arm are randomized to have a saline flush volume according to the IFU of the used device.
4xIFU
EXPERIMENTALSubjects in this arm are randomized to have a saline flush volume of 4x of what is stated in the IFU of the used device.
Interventions
Eligibility Criteria
You may qualify if:
- endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal
You may not qualify if:
- concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart and Vascular Center
Budapest, 1122, Hungary
Related Publications (1)
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.
PMID: 38586170DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Csaba Csobay-Novák, MD PhD
Dept. of Interventional Radiology, Heart and Vascular Center, Semmelweis University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief radiologist, Noninvasive Imaging
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 1, 2021
Study Start
June 10, 2021
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share