Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging (PAPAartis)
Aortic Aneurysm, Thoracoabdominal
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Thoracoabdominal focused on measuring Paraplegia, Aortic Aneurysm Repair, Staging, Embolization, TAAA, Thoracoabdominal aortic aneurysm, MISACE, Spinal cord ischemia, Spinal cord ischaemia, Spinal cord injury, Spinal cord ischemic injury, Spinal cord ischaemic injury, Permanent paraplegia, Temporary paraplegia, Paraparesis, SCI, TAAA repair, Open TAAA repair, Open surgical TAAA repair, Endovascular TAAA repair, TEVAR, Aortic surgery, Thoracoabdominal aortic surgery, Type B aortic dissection, Chronic type B aortic dissection, Stanford type B aortic dissection, Collateral network, Paraspinal collateral network, Paraspinous collateral network, Arteriogenesis, Intercostal arteries
Eligibility Criteria
Inclusion Criteria:
- TAAA, Crawford type II or III
- planned open or endovascular repair of aneurysm within four months
- ≥ 18 years old
Exclusion Criteria:
- complicated (sub-) acute type B aortic dissection
- ruptured and urgent aneurysm (emergencies)
- untreated aortic arch aneurysm
- bilaterally occluded iliac arteries or chronic total occlusion of left subclavian artery
- pre-operative neurological deficits or spinal cord dysfunction
- major untreated cardio-pulmonary disease
- life-expectancy of less than one year
- high risk for segmental artery embolism
- severe contrast agent allergy, severe reduction in glomerular filtration rate (CKD stage 4)
- expected lack of compliance
- pregnant or nursing women
- impaired thyroid function, if not under stable treatment
- women of child bearing potential without highly effective contraceptive measures
- current participation in other interventional clinical trial
- patients under legal supervision or guardianship
- patients placed in an institution by official or court order
Sites / Locations
- Medizinische Universität Innsbruck
- Herzzentrum Hietzing
- University Hospital of Bordeaux
- Marie Lannelongue Hospital
- Uniklinik RWTH Aachen
- Deutsches Herzzentrum Berlin
- Universitätsklinikum Düsseldorf
- Westdeutsches Herz und Gefäßzentrum Essen
- Universitäts-Herzzentrum Freiburg/ Bad KrozingenRecruiting
- Herzzentrum HamburgRecruiting
- Medizinische Hochschule Hannover
- Universitätsklinikum Heidelberg
- Herzzentrum LeipzigRecruiting
- UniversitätskIinikum LeipzigRecruiting
- Klinikum rechts der Isar (TU München)Recruiting
- Klinikum der Universität München (LMU)
- Universitätsklinikum Münster
- Paracelsus Universität - Klinikum Nürnberg
- Universitätsklinikum Regensburg
- Universitätsklinikum Tübingen
- S.Orsola-Malpighi Hospital
- Ospedale San Raffaele SRL
- Maastricht University Medical Center
- Medical University of Warsaw
- Silesian Center for Heart Diseases
- Lund University Hospital Malmoe
- Örebro University Hospital
- Bern University Hospital
- St Bartholomews Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
MISACE arm
control arm
Minimally-Invasive Segmental Artery Coil-Embolization MISACE procedure prior to aneurysm repair segmental arteries are occluded with coils or plugs in one to three MISACE sessions (staged procedure)
receives treatment of aneurysm as usual: open surgical repair or endovascular repair without MISACE