Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging with Minimally-Invasive Staged Segmental Artery Coil-Embolization: A Randomized Controlled Multicentre Trial
- Conditions
- Thoracoabdominal aortic aneurysm
- Registration Number
- DRKS00029921
- Lead Sponsor
- niversitätsklinikum Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 750
TAAA, Crawford types I, II or III or type B dissections of comparable extent; planned open or endovascular repair of aneurysm within four months; > 18 years old
complicated acute type B aortic dissection; 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; 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality - the most devastating complications resulting from aneurysm repair.
- Secondary Outcome Measures
Name Time Method The secondary objective of the trial will focus on further potential treatment advantages and/or risks of the MISACE-procedure (Minimally-Invasive Staged Segmental Artery Coil-Embolization).