SPIRIT: Study of the Patency of Spinal aRteries After the STABILISE Technique

NCT06373393 | Enrolling By Invitation

• 1 other identifier: 1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the impact of the stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in the patency of intercostal and lumbar arteries detectable on computed tomography angiography (CTA) in patients with type B aortic dissection and its correlation with the occurrence of spinal cord ischaemia (SCI). Primary end-point: patency of the intercostal and lumbar arteries on follow-up CTA. Secondary end-point: spinal cord ischaemia

Conditions

Aortic Dissection; Spinal Cord Ischemia

Keywords

aortic dissection; STABILISE; spinal cord ischemia; bare stent; stent-graft; endovascular repair

Outcome Measures

Primary Outcomes (1)

• number of patent intercostal and lumbar arteries

  number of patent intercostal and lumbar arteries after STABILISE

  baseline (pre op) and 1, 6, 12 and 24 months after surgery

Secondary Outcomes (1)

• number of patients with spinal cord ischemia

  baseline (pre op) and 1month after surgery

Interventions

STABILISE OTHER

STABILISE technique: "Stent assisted balloon induced intimal disruption and relamination in aortic dissection repair"

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 patients with type B aortic dissection submitted to the STABILISE technique

You may qualify if:

• patients with type B dissection treated according to the STABILISE technique

You may not qualify if:

• Aortic rupture.

Sponsors & Collaborators

• Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA: lead
• Cardiovascular Center of the University of Lisbon: collaborator
• Unidade Local de Saúde Santa Maria: collaborator

Study Sites (1)

Unidade Local de Saúde Santa Maria

Lisbon, 1500, Portugal

Location

MeSH Terms

Conditions

Aortic Dissection; Spinal Cord Ischemia

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Spinal Cord Vascular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: April 16, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)