Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373393
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-22
First Post:
2024-04-16
Brief Title:
SPIRIT Study of the Patency of Spinal aRteries After the STABILISE Technique
Sponsor:
Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
Organization:
Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
Study Overview
Official Title:
SPIRIT Study of the Patency of Spinal aRteries After the STABILISE Technique
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIRIT
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
Primary end-point patency of the intercostal and lumbar arteries on follow-up CTA
Secondary end-point spinal cord ischaemia
Detailed Description:
BACKGROUND AND STUDY INTRODUCTION
Endovascular treatment emerged over the last decade as the standard of care for complicated acute type B aortic dissection and the first step is usually the deployment of a thoracic endograft TEVAR aiming to cover the entry tear TEVAR may be enough to fix malperfusion syndromes but is frequently associated with late aortic dilatation and unfavorable remodeling 12 The failure of simple TEVAR to solve malperfusion syndromes led to the development of adjunctive techniques like direct stenting of the occluded arteries fenestration of the lamella or the association of a self-expandable bare stent deployment across the visceral and renal arteries to increase the true lumen diameter and improve perfusion of those arteries
The STABILISE technique to treat type B dissections is able to disrupt the lamella of the dissected aorta and consequently restore the uniluminal state of the aortic anatomy 345
The dissection process is related to the detachment of the aortic side branch ostia visceral renal iliacs intercostals lumbars and therefore a potential status of malperfusion which is often related to severe clinical complications that should be properly managed Additionally when the lamella is brought back to the peripheral aortic wall according to the STABILISE concept the recovery of perfusion from the true lumen is unclear
All these mechanisms as well as the cover of the ostia of upper intercostal arteries by the stentgraft may compromise the intercostal and lumbar arteries patency or the direct flow from the true lumen and therefore be related to the occurrence of spinal cord ischemia complications which prevalence was not yet determined 6-10
FEASIBILITY AND PRELIMINARY DATA
Our research group carried out a pilot study accepted for publication in the journal Journal of Vascular Surgery Cases Innovations and Techniques on patency of intercostal arteries after treatment of type B aortic dissection with the STABILIZE technique In this study we observed a decrease in the permeability of the intercostal arteries in the area of the thoracic endoprosthesis but we concluded that the permeability of the spinal arteries was not significantly affected by the coverage of the aorta with the uncovered stent nor by its aggressive ballooning to replace the intimal lamella These findings constitute a step towards a better understanding of the safety of this technique
STUDY DESIGN AND METHODS
This is a multi-center non-randomized retrospective observational analysis of patients treated with STABILISE technique for type B aortic dissection
The following data will be collected
preoperative comorbidities
temporal phase of dissection hyperacute acute subacute or chronic
procedural data diameter and length of the stentgrafts and bare stents and length of the covered aorta
occurrence of SCI at discharge and 30 days after procedure according to the TARLOV scale
Contrast-enhanced thoraco-abdominal CTA will be performed to patients pre-operatively and within 1 month 6 months and yearly after the procedure
Inclusion criteria
All patients with 18 years of age with a type B dissection treated according to the STABILISE technique
Exclusion criteria
- Aortic rupture
CTA protocol Contrast-enhanced thoraco-abdominal CTA with thin slices preferably 1mm will be performed to all patients pre-operatively and within 1 month 6 months and then yearly after the procedure Axial coronal and column curvature based maximum intensity projections MIP with 10mm slice thickness will be performed and analyzed retrospectively
After removing any patients identification the DICOM data will be sent via WeTransfer to the analysis center in Lisbon where the quantification and patency analysis will be performed
Results evaluation The CTA images will be semi-quantitatively analyzed by two independent investigators and the number of visible intercostal and lumbar arteries in the stented aorta stent-graft and dilated bare metal stent will be evaluated
The following parameters will be analyzed and reported in the attached sheet
PRE-TREATMENT CTA
Presence and patency of the intercostal and lumbar arteries specifying right and left sides
Origin of the intercostal and lumbar arteries - true lumen false lumen FL both - specifying right and left sides
POST-TREATMENT CTAs
Presence and patency of the intercostal and lumbar arteries specifying right and left sides
Origin of the intercostal and lumbar arteries TL FL both in cases where the uniluminal state was not completely restored specifying right and left sides
Patency of the distal portion of the intercostal and lumbar arteries when the ostium was covered by the stentgraft specifying right and left sides
Patency of the intercostal and lumbar arteries in the area of the bare stent specifying right and left sides
Patency of the intercostal and lumbar arteries in the area distal to the bare stent specifying right and left sides
All the assessed variables will be collected at the coordinating Center Santa Maria Hospital using the image data provided by the two participating centers
Endovascular treatment emerged over the last decade as the standard of care for complicated acute type B aortic dissection and the first step is usually the deployment of a thoracic endograft TEVAR aiming to cover the entry tear TEVAR may be enough to fix malperfusion syndromes but is frequently associated with late aortic dilatation and unfavorable remodeling 12 The failure of simple TEVAR to solve malperfusion syndromes led to the development of adjunctive techniques like direct stenting of the occluded arteries fenestration of the lamella or the association of a self-expandable bare stent deployment across the visceral and renal arteries to increase the true lumen diameter and improve perfusion of those arteries
The STABILISE technique to treat type B dissections is able to disrupt the lamella of the dissected aorta and consequently restore the uniluminal state of the aortic anatomy 345
The dissection process is related to the detachment of the aortic side branch ostia visceral renal iliacs intercostals lumbars and therefore a potential status of malperfusion which is often related to severe clinical complications that should be properly managed Additionally when the lamella is brought back to the peripheral aortic wall according to the STABILISE concept the recovery of perfusion from the true lumen is unclear
All these mechanisms as well as the cover of the ostia of upper intercostal arteries by the stentgraft may compromise the intercostal and lumbar arteries patency or the direct flow from the true lumen and therefore be related to the occurrence of spinal cord ischemia complications which prevalence was not yet determined 6-10
FEASIBILITY AND PRELIMINARY DATA
Our research group carried out a pilot study accepted for publication in the journal Journal of Vascular Surgery Cases Innovations and Techniques on patency of intercostal arteries after treatment of type B aortic dissection with the STABILIZE technique In this study we observed a decrease in the permeability of the intercostal arteries in the area of the thoracic endoprosthesis but we concluded that the permeability of the spinal arteries was not significantly affected by the coverage of the aorta with the uncovered stent nor by its aggressive ballooning to replace the intimal lamella These findings constitute a step towards a better understanding of the safety of this technique
STUDY DESIGN AND METHODS
This is a multi-center non-randomized retrospective observational analysis of patients treated with STABILISE technique for type B aortic dissection
The following data will be collected
preoperative comorbidities
temporal phase of dissection hyperacute acute subacute or chronic
procedural data diameter and length of the stentgrafts and bare stents and length of the covered aorta
occurrence of SCI at discharge and 30 days after procedure according to the TARLOV scale
Contrast-enhanced thoraco-abdominal CTA will be performed to patients pre-operatively and within 1 month 6 months and yearly after the procedure
Inclusion criteria
All patients with 18 years of age with a type B dissection treated according to the STABILISE technique
Exclusion criteria
- Aortic rupture
CTA protocol Contrast-enhanced thoraco-abdominal CTA with thin slices preferably 1mm will be performed to all patients pre-operatively and within 1 month 6 months and then yearly after the procedure Axial coronal and column curvature based maximum intensity projections MIP with 10mm slice thickness will be performed and analyzed retrospectively
After removing any patients identification the DICOM data will be sent via WeTransfer to the analysis center in Lisbon where the quantification and patency analysis will be performed
Results evaluation The CTA images will be semi-quantitatively analyzed by two independent investigators and the number of visible intercostal and lumbar arteries in the stented aorta stent-graft and dilated bare metal stent will be evaluated
The following parameters will be analyzed and reported in the attached sheet
PRE-TREATMENT CTA
Presence and patency of the intercostal and lumbar arteries specifying right and left sides
Origin of the intercostal and lumbar arteries - true lumen false lumen FL both - specifying right and left sides
POST-TREATMENT CTAs
Presence and patency of the intercostal and lumbar arteries specifying right and left sides
Origin of the intercostal and lumbar arteries TL FL both in cases where the uniluminal state was not completely restored specifying right and left sides
Patency of the distal portion of the intercostal and lumbar arteries when the ostium was covered by the stentgraft specifying right and left sides
Patency of the intercostal and lumbar arteries in the area of the bare stent specifying right and left sides
Patency of the intercostal and lumbar arteries in the area distal to the bare stent specifying right and left sides
All the assessed variables will be collected at the coordinating Center Santa Maria Hospital using the image data provided by the two participating centers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None