PAPAartis version 3.0
Research type
Research Study
Full title
Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging with ‘Minimally-Invasive Staged Segmental Artery Coil- Embolization’: A Randomized Controlled Multicentre Trial
IRAS ID
230945
Contact name
Aung Ye Oo
Contact email
Sponsor organisation
University Leipzig, University Hospital for Heart Surgery
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Based on statistics from the USA, one can estimate that 7,500 people per 100 Mio are diagnosed annually with an aortic aneurysm. Left untreated, the prognosis is very poor, since internal bleeding due to a rupture of the aneurysm brings about sudden death. If diameters have reached 60 mm, mortality is estimated to be 11%/year.
The repair of aortic aneurysms based on conventional stenting techniques have achieved a remarkable decrease in the incidence of paraplegia and paraparesis, but they still constitute an incidence of up to 20%.
At present there is a tremendous need for state of the art and safe strategies for aortic repair which prevent paraplegia - an individual disaster with profound impact on long-term outcome and health care cost.
The proposed clinical trial will support a proof of concept in humans to assess the clinical efficacy of a novel therapeutic concept: Aortic Aneurysm Repair by Thoracoabdominal Staging with ‘Minimally-Invasive Staged Segmental Artery coil-Embolization’ (MIS2ACE) to prevent paraplegia.REC name
London - Bromley Research Ethics Committee
REC reference
21/LO/0406
Date of REC Opinion
26 May 2021
REC opinion
Unfavourable Opinion