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Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging with ‘Minimally-Invasive Segmental Artery Coil-Embolization’: A Randomized Controlled Multicentre Trial

Objective

Chronic aortic aneurysms are permanent and localized dilations of the aorta that remain asymptomatic for long periods of time but continue to increase in diameter before they eventually rupture. Left untreated, the patients’ prognosis is dismal, since the internal bleeding of the rupture brings about sudden death. Although successful treatment cures the disease, the risky procedures can result in paraplegia from spinal cord ischaemia or even death, particularly for aneurysms extending from the thoracic to the abdominal aorta and thus involving many segmental arteries to the spinal cord, i.e. thoracoabdominal aortic aneurysms of Crawford type II. Although various strategies have achieved a remarkable decrease in the incidence of paraplegia, it is still no less than 10 to 20%. However, it has been found that the deliberate occlusion of the segmental arteries to the paraspinous collateral network finally supplying the spinal cord does not increase rates of permanent paraplegia. A therapeutic option, ‘minimally invasive segmental artery coil embolization’ has been devised which proceeds in a ‘staged’ way to occlude groups of arteries under highly controlled conditions after which time must be allowed for arteriogenesis to build a robust collateral blood supply. PAPA-ARTiS is a phase II trial to demonstrate that a staged treatment approach can reduce paraplegia and mortality dramatically. It can be expected to have both a dramatic impact on the individual patient's quality of life if saved from a wheelchair, and also upon financial systems through savings in; 1) lower costs in EU health care; 2) lower pay-outs in disability insurance (est. at 500k in Year 1), and; 3) loss of economic output from unemployment. Approx. 2500 patients a year in Europe undergo these high risk operations with a cumulative paraplegia rate of over 15%; therefore >100M per year in costs can be avoided and significantly more considering the expected elimination of type II endoleaks.

Field of science

  • /social sciences/sociology/demography/mortality

Call for proposal

H2020-SC1-2016-RTD
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITAET LEIPZIG
Address
Ritterstrasse 26
04109 Leipzig
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 535 455

Participants (25)

Insel Gruppe AG
Switzerland
EU contribution
€ 0
Address
Freiburgstrasse 18
3010 Bern
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA
Italy
EU contribution
€ 127 156,25
Address
Via Zamboni 33
40126 Bologna
Activity type
Higher or Secondary Education Establishments
UNIVERSITAETSKLINIKUM FREIBURG
Germany
EU contribution
€ 216 563,75
Address
Hugstetter Strasse 49
79106 Freiburg
Activity type
Higher or Secondary Education Establishments
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
Germany
EU contribution
€ 216 562,50
Address
Geschwister Scholl Platz 1
80539 Muenchen
Activity type
Higher or Secondary Education Establishments
UNIVERSITE DE LILLE II - DROIT ET SANTE

Participation ended

France
EU contribution
€ 0
Address
Rue Paul Duez 42
59800 Lille
Activity type
Higher or Secondary Education Establishments
UNIVERSITE DE LILLE

Participation ended

France
EU contribution
€ 0
Address
42 Rue Paul Duez
59800 Lille
Activity type
Higher or Secondary Education Establishments
LIVERPOOL HEART AND CHEST HOSPITAL NHS FOUNDATION TRUST

Participation ended

United Kingdom
EU contribution
€ 0
Address
Thomas Drive
L14 3PE Liverpool
Activity type
Research Organisations
ACADEMISCH ZIEKENHUIS MAASTRICHT
Netherlands
EU contribution
€ 223 852,50
Address
P Debyelaan 25
6229 HX Maastricht
Activity type
Research Organisations
SKANE LANS LANDSTING
Sweden
EU contribution
€ 221 302,50
Address
.
291 89 Kristianstad
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
WARSZAWSKI UNIWERSYTET MEDYCZNY
Poland
EU contribution
€ 131 875
Address
Ul. Zwirki I Wigury 61
02 091 Warszawa
Activity type
Higher or Secondary Education Establishments
OSPEDALE SAN RAFFAELE SRL
Italy
EU contribution
€ 166 368,75
Address
Via Olgettina 60
20132 Milano
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CHU HOPITAUX DE BORDEAUX
France
EU contribution
€ 159 820
Address
Rue Dubernat 12
33404 Talence
Activity type
Higher or Secondary Education Establishments
OREBRO LANS LANDSTING
Sweden
EU contribution
€ 229 575
Address
.
701 16 Orebro
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Germany
EU contribution
€ 216 565
Address
Martinistrasse 52
20251 Hamburg
Activity type
Higher or Secondary Education Establishments
SLASKIE CENTRUM CHOROB SERCA W ZABRZU
Poland
EU contribution
€ 119 910
Address
Ul. Marii Curie Sklodowskiej 9
41800 Zabrze
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSIDAD DE GRANADA
Spain
EU contribution
€ 262 596,25
Address
Cuesta Del Hospicio Sn
18071 Granada
Activity type
Higher or Secondary Education Establishments
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 364 750
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
KITE INNOVATION (EUROPE) LIMITED

Participation ended

United Kingdom
EU contribution
€ 6 816,25
Address
3M Buckley Innovation Centre
HD1 3BD Huddersfield
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
REGION HOVEDSTADEN
Denmark
EU contribution
€ 60 687,50
Address
Kongens Vaenge 2
3400 Hillerod
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
SOCIETE EUROPEENNE DE CARDIOLOGIE
France
EU contribution
€ 68 750
Address
Route Des Colles 2035
06903 Biot Sophia Antipolis
Activity type
Other
BAYLOR COLLEGE OF MEDICINE
United States
EU contribution
€ 50 420
Address
One Baylor Plaza T119
77030 Houston Tx
Activity type
Higher or Secondary Education Establishments
THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA CORP
United States
EU contribution
€ 50 420
Address
3451 Walnut Street Room P 221
19104 Philadelphia
Activity type
Higher or Secondary Education Establishments
MODUS RESEARCH AND INNOVATION LIMITED
United Kingdom
EU contribution
€ 104 006,25
Address
7-11 Melville Street
EH3 7PE Edinburgh
Activity type
Research Organisations
ASSOCIATION MARIE LANNELONGUE
France
EU contribution
€ 201 307,50
Address
Avenue De La Resistance 133
92350 Le Plessis Robinson
Activity type
Other
BARTS AND THE LONDON NHS TRUST
United Kingdom
EU contribution
€ 179 162,50
Address
Prescot Street 9
E1 8PR London
Activity type
Research Organisations