Status:
ACTIVE_NOT_RECRUITING
Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
European Commission
German Research Foundation
Conditions:
Aortic Aneurysm, Thoracoabdominal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- TAAA, Crawford type II or III
- planned open or endovascular repair of aneurysm within four months
- ≥ 18 years old
Exclusion
- 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
Key Trial Info
Start Date :
November 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03434314
Start Date
November 8 2018
End Date
June 1 2025
Last Update
April 11 2024
Active Locations (29)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria
2
Herzzentrum Hietzing
Vienna, Austria
3
University Hospital of Bordeaux
Bordeaux, France
4
Marie Lannelongue Hospital
Le Plessis-Robinson, France