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ACTIVE NOT RECRUITING
NCT03434314
NA

Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging

Sponsor: University of Leipzig

View on ClinicalTrials.gov

Summary

Aortic aneurysms represent the most common and dangerous aortic diseases. Although conventional aortic repair techniques cure the disease, there is a high risk of paraplegia particularly in extensive thoracoabdominal aneurysms due to impaired blood supply to the spinal cord. The PAPA-ARTiS trial will assess the clinical safety and efficacy of the MISACE (Minimally-Invasive Segmental Artery Coil-Embolization) procedure, a novel therapeutic concept to reduce the risk of paraplegia due to aneurysm repair. The study investigates the MISACE procedure as a potential pre-treatment prior to open or endovascular aneurysm repair in patients with thoracoabdominal aortic aneurysms. Patients will be randomized to one of the two treatment strategies: a) aneurysm repair without MISACE pre-treatment, or b) aneurysm repair with MISACE pre-treatment.

Official title: Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPAartis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2018-11-08

Completion Date

2025-06

Last Updated

2024-04-11

Healthy Volunteers

No

Interventions

PROCEDURE

Minimally-Invasive Segmental Artery Coil-Embolization

During one single MISACE session 3-7 segmental arteries will be occluded. The procedure is conducted through a peripheral artery access in local anaesthesia. Microcoils or vascular plugs will be used for the occlusion itself.

Locations (29)

Medizinische Universität Innsbruck

Innsbruck, Austria

Herzzentrum Hietzing

Vienna, Austria

University Hospital of Bordeaux

Bordeaux, France

Marie Lannelongue Hospital

Le Plessis-Robinson, France

Uniklinik RWTH Aachen

Aachen, Germany

Deutsches Herzzentrum Berlin

Berlin, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Westdeutsches Herz und Gefäßzentrum Essen

Essen, Germany

Universitäts-Herzzentrum Freiburg/ Bad Krozingen

Freiburg im Breisgau, Germany

Herzzentrum Hamburg

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Herzzentrum Leipzig

Leipzig, Germany

UniversitätskIinikum Leipzig

Leipzig, Germany

Klinikum rechts der Isar (TU München)

Munich, Germany

Klinikum der Universität München (LMU)

München, Germany

Universitätsklinikum Münster

Münster, Germany

Paracelsus Universität - Klinikum Nürnberg

Nuremberg, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

S.Orsola-Malpighi Hospital

Bologna, Italy

Ospedale San Raffaele SRL

Milan, Italy

Maastricht University Medical Center

Maastricht, Netherlands

Medical University of Warsaw

Warsaw, Poland

Silesian Center for Heart Diseases

Zabrze, Poland

Lund University Hospital Malmoe

Malmo, Sweden

Örebro University Hospital

Örebro, Sweden

Bern University Hospital

Bern, Switzerland

St Bartholomews Hospital

London, United Kingdom