Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging (NCT03434314) | Clinical Trial Compass
UnknownNot Applicable
Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging
Austria, France, Germany500 participantsStarted 2018-11-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality.