Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with ‘minimally invasive staged segmental artery coil embolisation’ (MIS²ACE): trial protocol for a randomised controlled multicentre trial
Key result
This trial protocol describes a randomized controlled trial to evaluate whether minimally invasive staged segmental artery coil embolization prevents spinal cord injury during aortic aneurysm repair.
Why the study?
Spinal cord injury is a common complication after thoracoabdominal aortic aneurysm repair, and staged segmental artery coil embolisation promises protection by inducing arteriogenesis.
Does minimally invasive staged segmental artery coil embolisation (MIS²ACE) prior to aneurysm repair prevent spinal cord injury in patients with thoracoabdominal aortic aneurysms?
Population
500 patients undergoing planned open or endovascular thoracoabdominal aortic aneurysm repair
Comparison
MIS 2 ACE in 1-3 sessions followed by repair vs standard aneurysm repair
Design
Multicentre, multinational, parallel-group randomised controlled trial protocol
Follow-up
30 days for primary endpoint, up to 1 year for mortality
Authors
Discussion
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Member takes
Implication
MIS²ACE feasibility supports staged preconditioning before TAAA repair; RCT results needed to confirm efficacy.
Study Design
Type
RCT (n=500)
Randomization
1:1
Multicenter
Yes
Structured PICO
Does minimally invasive staged segmental artery coil embolisation (MIS²ACE) prior to aneurysm repair prevent spinal cord injury in patients with thoracoabdominal aortic aneurysms?
P
Population
500 patients planned for open or endovascular repair of thoracoabdominal aortic aneurysms, randomized to standard repair or staged coil embolization.
I
Intervention
Minimally invasive staged segmental artery coil embolisation (MIS²ACE) in 1-3 sessions followed by aneurysm repair
C
Comparator
Standard aneurysm repair
O
Outcome
Successful aneurysm repair without substantial spinal cord injury (SCI) 30 days after aneurysm repaircomposite
This trial protocol describes a randomized study to evaluate whether minimally invasive staged segmental artery coil embolization prior to thoracoabdominal aortic aneurysm repair reduces the incidence of spinal cord injury.
Cite This Study
Petroff et al. (2019) conducted an RCT in Thoracoabdominal aortic aneurysms (n=500). Minimally invasive staged segmental artery coil embolisation (MIS²ACE) vs. Standard aneurysm repair was evaluated on Successful aneurysm repair without substantial spinal cord injury 30 days after aneurysm repair. This trial protocol describes a randomized controlled trial to evaluate whether minimally invasive staged segmental artery coil embolization prevents spinal cord injury during aortic aneurysm repair.