Thoracoabdominal Aortic AneurysmSafe-line-techNCT05758844
The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA
An observational study of Thoracoabdominal Aortic Aneurysm, run by University Hospital Padova at 1 site in Italy.
Trial summary
To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- What is being tested?
- safe-line technique
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2023to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion of all patients treated for thoraco abdominal aortic aneurysm with endovascular repair and use of safe line technique
Who may be able to join
- Thoraco-abdominal aortic aneurysm including type I,II,III,IV and V.
- Pararenale aneurysm
- Thoracoabdominal aortic aneurysm Elective and Urgent, endovascular repair;
- Endovascular repair of any thoracoabdominal aortic condition
Who cannot join
- -thoraco-abdominal aortic aneurysm open repair
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francesco Squizzato, MD contact
Italy1 site, 1 recruiting
- Recruiting
Vascular and Endovascular Clinic - Padova University
Padova, 35020
Michele Piazza, Pr, 3498644688, michele.piazza@unipd.it
About this study
Official title: The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair
To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.
Read the detailed description
To assess safety and efficacy of a technique for temporary aneurysm sac re-perfusion (TASreP) after total endovascular exclusion of TAAA, using a guide-wire left into the aneurysm sac. The technique can be applied both in elective that urgent cases.
The guide-wire aim to be a "safe-line" for fast temporary trans-sealing aneurysm sac re-perfusion in case of SCI occurring in the early post-operative period (48-to 72h).
Before completing exclusion, from the percutaneous femoral access, a second buddy-wire (V-18 guidewire; Boston Scientific) is advanced and left posterior to the endograft into the aneurysmal sac; through the main guide-wire, the final aneurysm exclusion is completed with distal stent-graft deployment and the femoral access sealed with Proglide leaving in place the sole V.018 draped in a sterile fashion. In the case of SCI occurrence in the post-operative period up to 48-72 hrs, the trans-sealing V.18 "safe-line" can be rapidly exchanged with a 6F/65 cm long Destination cm guiding sheath (Terumo) and positioned into the aneurysmal sac; this can be connected to a 6F introducer from the contralateral femoral artery and the sac perfused in a retrograde fashion.
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Being tested
- safe-line technique
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safe-line techniqueProcedure or surgery
Safe-line approach
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
collect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma)
Measured: 7 days
Incidence of spinal cord ischemia improvement or resolution
collect all events that in case of post-operative (48-72hrs) spinal cord ischemia had symptoms mitigation (1-paraplegia improvement; 2 - paraplegia complete resolution)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start30 Apr 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Piazza, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758844
- Sponsor's protocol ID
- Safe-line.1
- Acronym
- Safe-line-tech
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With other partecipating centers
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair
- ClinicalTrials.gov ID
- NCT05758844
- Acronym / sponsor ID
- Safe-line-tech / Safe-line.1
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Mar 2023 (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.
To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.
Detailed description
To assess safety and efficacy of a technique for temporary aneurysm sac re-perfusion (TASreP) after total endovascular exclusion of TAAA, using a guide-wire left into the aneurysm sac. The technique can be applied both in elective that urgent cases.
The guide-wire aim to be a "safe-line" for fast temporary trans-sealing aneurysm sac re-perfusion in case of SCI occurring in the early post-operative period (48-to 72h).
Before completing exclusion, from the percutaneous femoral access, a second buddy-wire (V-18 guidewire; Boston Scientific) is advanced and left posterior to the endograft into the aneurysmal sac; through the main guide-wire, the final aneurysm exclusion is completed with distal stent-graft deployment and the femoral access sealed with Proglide leaving in place the sole V.018 draped in a sterile fashion. In the case of SCI occurrence in the post-operative period up to 48-72 hrs, the trans-sealing V.18 "safe-line" can be rapidly exchanged with a 6F/65 cm long Destination cm guiding sheath (Terumo) and positioned into the aneurysmal sac; this can be connected to a 6F introducer from the contralateral femoral artery and the sac perfused in a retrograde fashion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion of all patients treated for thoraco abdominal aortic aneurysm with endovascular repair and use of safe line technique
Key inclusion criteria (4 listed)
- Thoraco-abdominal aortic aneurysm including type I,II,III,IV and V.
- Pararenale aneurysm
- Thoracoabdominal aortic aneurysm Elective and Urgent, endovascular repair;
- Endovascular repair of any thoracoabdominal aortic condition
Key exclusion criteria (1 listed)
- -thoraco-abdominal aortic aneurysm open repair
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 |
|---|---|---|
| safe-line techniqueSafe-line approach | Procedure or surgery | – |
Primary outcome
Incidence of adverse events
Time frame: 7 days
collect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma)
Incidence of spinal cord ischemia improvement or resolution
Time frame: 30 days
collect all events that in case of post-operative (48-72hrs) spinal cord ischemia had symptoms mitigation (1-paraplegia improvement; 2 - paraplegia complete resolution)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Yes. With other partecipating centers
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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.
Francesco Squizzato, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoabdominal Aortic Aneurysm, run by University Hospital Padova at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 8 Mar 2023. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Piazza, Pr. (3498644688, michele.piazza@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 7 days). The study lists 2 primary outcomes in all. 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 8 Mar 2023.