An interventional study of Minimally-Invasive Segmental Artery Coil-Embolization in Aortic Aneurysm, Thoracoabdominal, sponsored by University of Leipzig. Active, not recruiting at 29 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by University of Leipzig · Not applicable, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 500 is above the median of 80 across 41 interventional studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →University of Leipzig is the lead sponsor of 148 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Procedure: Minimally-Invasive Segmental Artery Coil-Embolization
receives treatment of aneurysm as usual: open surgical repair or endovascular repair without MISACE
During one single MISACE session 3-7 segmental arteries will be occluded. The procedure is conducted through a peripheral artery access in local anaesthesia. Microcoils or vascular plugs will be used for the occlusion itself.
The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality.
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).
Time frame: 30 days after TAAA repair
substantial spinal cord injury
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. Normal
Time frame: 30 days after TAAA repair and at one year after TAAA repair
spinal cord injury according to the modified Tarlov scale from TAAA repair to one year
Spinal cord injury will be determined with a modified Tarlov scale (see above).
Time frame: from date of TAAA repair and up to one year after TAAA repair
mortality
all-cause mortality
Time frame: at 30 days and one year after TAAA repair
stay in intensive care unit and intermediate care
length of stay in intensive care unit and intermediate care unit after TAAA repair
Time frame: from date of TAAA repair and up to one year after TAAA repair
sub-group analyses
sub-group analyses of spinal cord injury according to modified Tarlov scale (see above) for open repair and endovascular repair separately
Time frame: up to one year after TAAA repair
sub-group analyses
sub-group analyses of mortality for open repair and endovascular repair separately
Time frame: up to one year after TAAA repair
re-operation for bleeding
re-operation for bleeding (only for open repair)
Time frame: from date of TAAA repair and up to one year after TAAA repair
cross-clamping times
cross-clamping times during open surgery
Time frame: during open surgery
residual aneurysm sac perfusion
residual aneurysm sac perfusion, i.e. type II endoleaks (only for endovascular repair)
Time frame: up to one year after TAAA repair
costs
incremental cost-effectiveness ratio (ICER) will be calculated
Time frame: up to one year after TAAA repair
Quality Adjusted Life Years
Quality Adjusted Life Years (QALYs) will be estimated over one year
Time frame: up to one year after TAAA repair
Plan to share: Undecided
Started Nov 2018 (actual). Primary completion is estimated for Jun 2025, 79 months after the start.
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This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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