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NCT Number: NCT05758844

The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA

To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vascular and Endovascular Clinic - Padova University

Padova, 35020, Italy

Location status: Recruiting

Location contact

Michele Piazza, Pr

CONTACT

[email protected]

3498644688

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-thoraco-abdominal aortic aneurysm open repair

Treatment and study plan

safe-line technique

Procedure

Safe-line approach

Primary outcomes

  1. Incidence of adverse events

    Time frame: 7 days

    collect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Squizzato, MD

CONTACT

[email protected]

Michele Piazza, Pr.

CONTACT

[email protected]

3498644688

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair

Acronym: Safe-line-tech

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 8, 2023
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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