Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Interventions
- Procedure: Minimally-Invasive Segmental Artery Coil-Embolization
- Registration Number
- NCT03434314
- Lead Sponsor
- University of Leipzig
- 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 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.
- 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 untreated, the patients' prognosis is dismal, since the internal bleeding of the rupture brings about sudden death. Although successful treatment cures the disease, the risky procedures compromise spinal cord blood supply acutely and permanently, frequently leading to paraplegia, particularly for aneurysms involving crucial segmental arteries, i.e. thoracoabdominal aortic aneurysms of Crawford type II \& III. Although various strategies have achieved a remarkable decrease in the incidence of paraplegia, it is still no less than 10-20%.
However, it has recently been found that the deliberate staged occlusion of the segmental arteries to the paraspinous collateral network finally supplying the spinal cord can trigger arterial collateralization, thus stabilizing blood supply from alternate inflow sources and preventing ischaemia.
This has been translated to a clinically available therapeutic option, 'minimally invasive staged segmental artery coil embolization' (MISACE), which proceeds in a 'staged' manner to occlude groups of arteries under highly controlled conditions, after which time must be allowed for arteriogenesis to build a robust collateral blood supply.
PAPA-ARTiS is a multi-national, prospective, open-label, two-arm, randomized controlled trial to demonstrate, that a minimally invasive staged treatment approach can reduce paraplegia and mortality in patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair.
Patients with planned aneurysm repair will be included in the study and will be randomized 1:1 in the control group or the MISACE-group. The control group receives treatment as per standard institutional protocol - open or endovascular repair without MISACE. In the MISACE-group, segmental arteries will be occluded in one to three sessions some weeks before the definite repair. Segmental arteries are occluded with coils or plugs.This induces arteriogenesis and the building of a robust collateral network ultimately supplying the spinal cord. During aneurysm repair, these new arteries provide an alternate blood supply to the spinal cord and thereby help prevent paraplegia.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- TAAA, Crawford type II or III
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MISACE arm Minimally-Invasive Segmental Artery Coil-Embolization 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)
- Primary Outcome Measures
Name Time Method The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality. 30 days after TAAA repair Successful treatment of the aneurysm is a binary variable. All of the following criteria must be met for this composite endpoint to count as a success:
* The patient is alive and without substantial spinal cord injury 30 days after treatment, and
* the aneurysm did not rupture and has been excluded within six months of randomization. Substantial spinal cord injury will be determined with a modified Tarlov scale (see below).
- Secondary Outcome Measures
Name Time Method Quality Adjusted Life Years up to one year after TAAA repair Quality Adjusted Life Years (QALYs) will be estimated over one year
spinal cord injury according to the modified Tarlov scale from TAAA repair to one year from date of TAAA repair and up to one year after TAAA repair Spinal cord injury will be determined with a modified Tarlov scale (see above).
mortality at 30 days and one year after TAAA repair all-cause mortality
sub-group analyses up to one year after TAAA repair sub-group analyses of mortality for open repair and endovascular repair separately
re-operation for bleeding from date of TAAA repair and up to one year after TAAA repair re-operation for bleeding (only for open repair)
substantial spinal cord injury 30 days after TAAA repair and at one year after TAAA repair Substantial spinal cord injury is defined as zero to two on the modified Tarlov scale.
0. No lower extremity movement
1. Lower extremity motion without gravity
2. Lower extremity motion against gravity
3. Able to stand with assistance
4. Able to walk with assistance
5. Normalstay in intensive care unit and intermediate care from date of TAAA repair and up to one year after TAAA repair length of stay in intensive care unit and intermediate care unit after TAAA repair
cross-clamping times during open surgery cross-clamping times during open surgery
residual aneurysm sac perfusion up to one year after TAAA repair residual aneurysm sac perfusion, i.e. type II endoleaks (only for endovascular repair)
costs up to one year after TAAA repair incremental cost-effectiveness ratio (ICER) will be calculated
Trial Locations
- Locations (29)
Marie Lannelongue Hospital
🇫🇷Le Plessis-Robinson, France
Uniklinik RWTH Aachen
🇩🇪Aachen, Germany
Herzzentrum Hietzing
🇦🇹Vienna, Austria
University Hospital of Bordeaux
🇫🇷Bordeaux, France
Universitätsklinikum Münster
🇩🇪Münster, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Herzzentrum Hamburg
🇩🇪Hamburg, Germany
Westdeutsches Herz und Gefäßzentrum Essen
🇩🇪Essen, Germany
Ospedale San Raffaele SRL
🇮🇹Milano, Italy
Silesian Center for Heart Diseases
🇵🇱Zabrze, Poland
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Paracelsus Universität - Klinikum Nürnberg
🇩🇪Nuremberg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
S.Orsola-Malpighi Hospital
🇮🇹Bologna, Italy
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Medical University of Warsaw
🇵🇱Warsaw, Poland
Lund University Hospital Malmoe
🇸🇪Malmö, Sweden
Bern University Hospital
🇨🇭Bern, Switzerland
Örebro University Hospital
🇸🇪Örebro, Sweden
St Bartholomews Hospital
🇬🇧London, United Kingdom
Universitäts-Herzzentrum Freiburg/ Bad Krozingen
🇩🇪Freiburg, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
UniversitätskIinikum Leipzig
🇩🇪Leipzig, Germany
Klinikum rechts der Isar (TU München)
🇩🇪Munich, Germany
Klinikum der Universität München (LMU)
🇩🇪München, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria