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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.

Call for proposal

H2020-SC1-2016-2017

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Sub call

H2020-SC1-2016-RTD

Coordinator

UNIVERSITAET LEIPZIG
Net EU contribution
€ 2 154 905,00
Address
Ritterstrasse 26
04109 Leipzig
Germany

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Region
Sachsen Leipzig Leipzig
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (32)

Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITATKLINIKUM LEIPZIG
Germany
Net EU contribution
€ 190 275,00
Address
Liebigstrasse 27
04103 Leipzig

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Region
Sachsen Leipzig Leipzig
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

HERZZENTRUM LEIPZIG GMBH
Germany
Net EU contribution
€ 190 275,00
Address
Struempellstrasse 39
04289 Leipzig

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Region
Sachsen Leipzig Leipzig
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
INSEL GRUPPE AG
Switzerland
Net EU contribution
€ 0,00
Address
Freiburgstrasse 18
3010 Bern

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Region
Schweiz/Suisse/Svizzera Espace Mittelland Bern / Berne
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 222 500,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITAET BERN
Switzerland
Net EU contribution
€ 0,00
Address
Hochschulstrasse 6
3012 Bern

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Region
Schweiz/Suisse/Svizzera Espace Mittelland Bern / Berne
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 51 250,00
ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA
Italy
Net EU contribution
€ 67 750,00
Address
Via Zamboni 33
40126 Bologna

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Nord-Est Emilia-Romagna Bologna
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

IRCCS AZIENDA OSPEDALIERO- UNIVERSITARIA DI BOLOGNA
Italy
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€ 59 406,25
Address
Via Albertoni 15
40138 Bologna

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Nord-Est Emilia-Romagna Bologna
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€ 0,00
UNIVERSITAETSKLINIKUM FREIBURG
Germany
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€ 216 563,75
Address
Hugstetter Strasse 49
79106 Freiburg

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Baden-Württemberg Freiburg Freiburg im Breisgau, Stadtkreis
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Higher or Secondary Education Establishments
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€ 0,00
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
Germany
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€ 216 562,50
Address
Geschwister Scholl Platz 1
80539 Muenchen

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Bayern Oberbayern München, Kreisfreie Stadt
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Higher or Secondary Education Establishments
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€ 0,00
UNIVERSITE DE LILLE

Participation ended

France
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€ 0,00
Address
42 Rue Paul Duez
59000 Lille

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Hauts-de-France Nord-Pas de Calais Nord
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Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE

Participation ended

France
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€ 0,00
Address
Avenue Oscar Lambret 2
59037 Lille

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Region
Hauts-de-France Nord-Pas de Calais Nord
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
LIVERPOOL HEART AND CHEST HOSPITAL NHS FOUNDATION TRUST

Participation ended

United Kingdom
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€ 0,00
Address
Thomas Drive
L14 3PE Liverpool

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North West (England) Merseyside Liverpool
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ACADEMISCH ZIEKENHUIS MAASTRICHT
Netherlands
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€ 223 852,50
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P Debyelaan 25
6229 HX Maastricht

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Limburg (NL) Zuid-Limburg
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€ 0,00
SKANE LANS LANDSTING
Sweden
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€ 221 302,50
Address
.
291 89 Kristianstad

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Södra Sverige Sydsverige Skåne län
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€ 0,00
WARSZAWSKI UNIWERSYTET MEDYCZNY
Poland
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€ 131 875,00
Address
Ul. Zwirki I Wigury 61
02 091 Warszawa

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Makroregion województwo mazowieckie Warszawski stołeczny Miasto Warszawa
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€ 0,00
OSPEDALE SAN RAFFAELE SRL
Italy
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€ 166 368,75
Address
Via Olgettina 60
20132 Milano

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Nord-Ovest Lombardia Milano
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CHU HOPITAUX DE BORDEAUX
France
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€ 159 820,00
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Rue Dubernat 12
33404 Talence

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Nouvelle-Aquitaine Aquitaine Gironde
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€ 0,00
OREBRO LANS LANDSTING
Sweden
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€ 229 575,00
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701 16 Orebro

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Östra Sverige Östra Mellansverige Örebro län
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€ 0,00
UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Germany
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€ 216 565,00
Address
Martinistrasse 52
20251 Hamburg

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Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
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€ 0,00
SLASKIE CENTRUM CHOROB SERCA W ZABRZU
Poland
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€ 119 910,00
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Ul. Marii Curie Sklodowskiej 9
41800 Zabrze

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Makroregion południowy Śląskie Gliwicki
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€ 0,00
UNIVERSIDAD DE GRANADA
Spain
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€ 262 596,25
Address
Cuesta Del Hospicio Sn
18071 Granada

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Andalucía Granada
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€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
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€ 322 491,50
Address
5 Rue Watt
75013 Paris

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Ile-de-France Ile-de-France Paris
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Non-EU contribution
€ 0,00
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KLINIKUM DER UNIVERSITAET ZU KOELN

Participation ended

Germany
Net EU contribution
€ 3 623,75
Address
Kerpener Strasse 62
50937 Koeln

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Nordrhein-Westfalen Köln Köln, Kreisfreie Stadt
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Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KKS-NETZWERK EV -NETZWERK DER KOORDINIERUNGSZENTREN FUR KLINISCHE STUDIEN
Germany
Net EU contribution
€ 26 376,25
Address
Alt-moabit 96 A
10559 Berlin

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Berlin Berlin Berlin
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
Net EU contribution
€ 51 862,50
Address
3 Avenue Victoria
75000 Paris

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Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
KITE INNOVATION (EUROPE) LIMITED

Participation ended

United Kingdom
Net EU contribution
€ 6 816,25
Address
3m Buckley Innovation Centre
HD1 3BD Huddersfield

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Yorkshire and the Humber West Yorkshire Calderdale and Kirklees
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
REGION HOVEDSTADEN
Denmark
Net EU contribution
€ 60 687,50
Address
Kongens Vaenge 2
3400 Hillerod

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Region
Danmark Hovedstaden Nordsjælland
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Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
SOCIETE EUROPEENNE DE CARDIOLOGIE
France
Net EU contribution
€ 68 750,00
Address
Route Des Colles 2035
06903 Biot Sophia Antipolis

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Region
Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Alpes-Maritimes
Activity type
Other
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€ 0,00
BAYLOR COLLEGE OF MEDICINE
United States
Net EU contribution
€ 50 420,00
Address
One Baylor Plaza T119
77030 Houston Tx

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Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA CORP
United States
Net EU contribution
€ 50 420,00
Address
3451 Walnut Street Room P 221
19104 Philadelphia

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Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
MODUS RESEARCH AND INNOVATION LIMITED
United Kingdom
Net EU contribution
€ 104 006,25
Address
7-11 Melville Street
EH3 7PE Edinburgh

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Eastern Scotland Edinburgh
Activity type
Research Organisations
Non-EU contribution
€ 0,00
ASSOCIATION MARIE LANNELONGUE
France
Net EU contribution
€ 161 703,50
Address
Avenue De La Resistance 133
92350 Le Plessis Robinson

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Region
Ile-de-France Ile-de-France Hauts-de-Seine
Activity type
Other
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€ 0,00
BARTS AND THE LONDON NHS TRUST
United Kingdom
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€ 179 162,50
Address
Prescot Street 9
E1 8PR London

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Region
London Inner London — East Tower Hamlets
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Research Organisations
Non-EU contribution
€ 0,00