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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

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.

Coordinator

UNIVERSITAET LEIPZIG

Address

Ritterstrasse 26
04109 Leipzig

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 2 535 455

Participants (23)

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Insel Gruppe AG

Switzerland

ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA

Italy

EU Contribution

€ 127 156,25

UNIVERSITAETSKLINIKUM FREIBURG

Germany

EU Contribution

€ 216 563,75

LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN

Germany

EU Contribution

€ 216 562,50

UNIVERSITE DE LILLE II - DROIT ET SANTE

France

UNIVERSITE DE LILLE

France

EU Contribution

€ 201 307,50

LIVERPOOL HEART AND CHEST HOSPITAL NHS FOUNDATION TRUST

United Kingdom

EU Contribution

€ 179 162,50

ACADEMISCH ZIEKENHUIS MAASTRICHT

Netherlands

EU Contribution

€ 223 852,50

SKANE LANS LANDSTING

Sweden

EU Contribution

€ 221 302,50

WARSZAWSKI UNIWERSYTET MEDYCZNY

Poland

EU Contribution

€ 131 875

OSPEDALE SAN RAFFAELE SRL

Italy

EU Contribution

€ 166 368,75

CHU HOPITAUX DE BORDEAUX

France

EU Contribution

€ 159 820

OREBRO LANS LANDSTING

Sweden

EU Contribution

€ 229 575

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF

Germany

EU Contribution

€ 216 565

SLASKIE CENTRUM CHOROB SERCA W ZABRZU

Poland

EU Contribution

€ 119 910

UNIVERSIDAD DE GRANADA

Spain

EU Contribution

€ 262 596,25

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 364 750

KITE INNOVATION (EUROPE) LIMITED

United Kingdom

EU Contribution

€ 6 816,25

REGION HOVEDSTADEN

Denmark

EU Contribution

€ 60 687,50

SOCIETE EUROPEENNE DE CARDIOLOGIE

France

EU Contribution

€ 68 750

BAYLOR COLLEGE OF MEDICINE

United States

EU Contribution

€ 50 420

THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA CORP

United States

EU Contribution

€ 50 420

MODUS RESEARCH AND INNOVATION LIMITED

United Kingdom

EU Contribution

€ 104 006,25

Project information

Grant agreement ID: 733203

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 6 187 672,50

  • EU contribution

    € 5 913 922,50

Coordinated by:

UNIVERSITAET LEIPZIG

Germany