Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging with *Minimally- Invasive Staged Segmental Artery Coil- Embolization*: A Randomized Controlled Multicentre Trial
- Conditions
- Aneurysm10002363
- Registration Number
- NL-OMON56465
- Lead Sponsor
- niversity of Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 22
• TAAA, Crawford type 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 (sub-) acute type B aortic dissection
• ruptured and urgent aneurysm (emergencies)
• untreated aortic arch aneurysm (patients with a previous
successful aortic arch aneurysm repair may be included
independent of technique used)
• 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 (*shaggy* aorta, i.e.
prominent thromboembolic or atherosclerotic debris)
• severe contrast agent allergy, severe reduction in glomerular
filtration rate (CKD stage 4)
• expected lack of compliance (e.g. if the patient may not be
willing to have several MIS2ACE sessions and the following
repair)
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>Successful treatment of the aneurysm. That means:<br /><br>• The patient is alive and without substantial SCI 30 days after treatment, and<br /><br>• the aneurysm did not rupture and has been excluded within six months of<br /><br>randomization.</p><br>
- Secondary Outcome Measures
Name Time Method