Aortic Aneurysm, ThoracoabdominalPAPAartisNCT03434314
Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging
A study testing Minimally-Invasive Segmental Artery Coil-Embolization in people with Aortic Aneurysm, Thoracoabdominal, run by University of Leipzig at 29 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracoabdominal
- What is being tested?
- Minimally-Invasive Segmental Artery Coil-Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 29 sitesin 9 countries
- Study dates
- 8 Nov 2018to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TAAA, Crawford type II or III
- planned open or endovascular repair of aneurysm within four months
- ≥ 18 years old
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
29 sites in 9 countries.
29 sites in 9 countries
Germany16 sites
Uniklinik RWTH Aachen
Aachen
Deutsches Herzzentrum Berlin
Berlin
Universitätsklinikum Düsseldorf
Düsseldorf
Westdeutsches Herz und Gefäßzentrum Essen
Essen
Universitäts-Herzzentrum Freiburg/ Bad Krozingen
Freiburg im Breisgau
Herzzentrum Hamburg
Hamburg
Medizinische Hochschule Hannover
Hanover
Universitätsklinikum Heidelberg
Heidelberg
Herzzentrum Leipzig
Leipzig
UniversitätskIinikum Leipzig
Leipzig
Klinikum der Universität München (LMU)
München
Klinikum rechts der Isar (TU München)
Munich
Universitätsklinikum Münster
Münster
Paracelsus Universität - Klinikum Nürnberg
Nuremberg
Universitätsklinikum Regensburg
Regensburg
Universitätsklinikum Tübingen
Tübingen
Austria2 sites
Medizinische Universität Innsbruck
Innsbruck
Herzzentrum Hietzing
Vienna
France2 sites
University Hospital of Bordeaux
Bordeaux
Marie Lannelongue Hospital
Le Plessis-Robinson
Poland2 sites
Medical University of Warsaw
Warsaw
Silesian Center for Heart Diseases
Zabrze
Sweden2 sites
Lund University Hospital Malmoe
Malmö
Örebro University Hospital
Örebro
About this study
Official title: Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPAartis
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.
Read the 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.
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Being tested
- Minimally-Invasive Segmental Artery Coil-Embolization
- Keywords
- Paraplegia, Aortic Aneurysm Repair, Staging, Embolization, TAAA, Thoracoabdominal aortic aneurysm, MISACE, Spinal cord ischemia, Spinal cord ischaemia, Spinal cord injury, Spinal cord ischemic injury, Spinal cord ischaemic injury, Permanent paraplegia, Temporary paraplegia, Paraparesis, SCI, TAAA repair, Open TAAA repair, Open surgical TAAA repair, Endovascular TAAA repair
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Paraplegia, Spinal Cord Ischemia, Spinal Cord Injuries, Paraparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally-Invasive Segmental Artery Coil-EmbolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| MISACE arm | Experimental | 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) Receives: Procedure: Minimally-Invasive Segmental Artery Coil-Embolization |
| control arm | No intervention | receives treatment of aneurysm as usual: open surgical repair or endovascular repair without MISACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days after TAAA repair
Secondary outcomes (11)
substantial spinal cord injury
Substantial spinal cord injury is defined as zero to two on the modified Tarlov scale.
- No lower extremity movement
- Lower extremity motion without gravity
- Lower extremity motion against gravity
- Able to stand with assistance
- Able to walk with assistance
- Normal
Measured: 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).
Measured: from date of TAAA repair and up to one year after TAAA repair
mortality
all-cause mortality
Measured: 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
Measured: 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
Measured: up to one year after TAAA repair
sub-group analyses
sub-group analyses of mortality for open repair and endovascular repair separately
Measured: up to one year after TAAA repair
re-operation for bleeding
re-operation for bleeding (only for open repair)
Measured: from date of TAAA repair and up to one year after TAAA repair
cross-clamping times
cross-clamping times during open surgery
Measured: during open surgery
residual aneurysm sac perfusion
residual aneurysm sac perfusion, i.e. type II endoleaks (only for endovascular repair)
Measured: up to one year after TAAA repair
costs
incremental cost-effectiveness ratio (ICER) will be calculated
Measured: up to one year after TAAA repair
Quality Adjusted Life Years
Quality Adjusted Life Years (QALYs) will be estimated over one year
Measured: up to one year after TAAA repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start8 Nov 2018
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, ThoracoabdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, German Research Foundation, Universidad de Granada, European Clinical Research Infrastructure Network, Modus Research and Innovation Limited, Copenhagen University Hospital, Rigshospitalet, European Society of Cardiology, Baylor College of Medicine, University of Pennsylvania
- Responsible party
- Principal investigator, David Petroff, University of Leipzig
- Investigators
- Christian D Etz, Prof. Dr., Principal investigator, University Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434314
- Sponsor's protocol ID
- PAPAartis
- Other IDs
- 733203, ET 127/2-1
- Acronym
- PAPAartis
- Status last verified
- Apr 2024
- First submitted
- 12 Jan 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Petroff D, Czerny M, Kolbel T, Melissano G, Lonn L, Haunschild J, von Aspern K, Neuhaus P, Pelz J, Epstein DM, Romo-Aviles N, Piotrowski K, Etz CD. Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS(2)ACE): trial protocol for a randomised controlled multicentre trial. BMJ Open. 2019 Mar 4;9(3):e025488. doi: 10.1136/bmjopen-2018-025488.
PubMed 30837256
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPAartis
- ClinicalTrials.gov ID
- NCT03434314
- Acronym / sponsor ID
- PAPAartis / PAPAartis
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Keywords
- Paraplegia, Aortic Aneurysm Repair, Staging, Embolization, TAAA, Thoracoabdominal aortic aneurysm, MISACE, Spinal cord ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- European Commission, German Research Foundation, Universidad de Granada, European Clinical Research Infrastructure Network, Modus Research and Innovation Limited, Copenhagen University Hospital, Rigshospitalet, European Society of Cardiology, Baylor College of Medicine, University of Pennsylvania
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MISACE arm | Experimental | Procedure: Minimally-Invasive Segmental Artery Coil-EmbolizationMinimally-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) |
| control arm | No intervention | –receives treatment of aneurysm as usual: open surgical repair or endovascular repair without MISACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- TAAA, Crawford type II or III
- planned open or endovascular repair of aneurysm within four months
- ≥ 18 years old
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally-Invasive Segmental Artery Coil-EmbolizationDuring 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. | Procedure or surgery | MISACE arm |
Primary outcome
The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality.
Time frame: 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).
11 secondary outcomes
substantial spinal cord injury
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
Time frame: from date of TAAA repair and up to one year after TAAA repair
mortality
Time frame: at 30 days and one year after TAAA repair
stay in intensive care unit and intermediate care
Time frame: from date of TAAA repair and up to one year after TAAA repair
sub-group analyses
Time frame: up to one year after TAAA repair
sub-group analyses
Time frame: up to one year after TAAA repair
re-operation for bleeding
Time frame: from date of TAAA repair and up to one year after TAAA repair
cross-clamping times
Time frame: during open surgery
residual aneurysm sac perfusion
Time frame: up to one year after TAAA repair
costs
Time frame: up to one year after TAAA repair
Quality Adjusted Life Years
Time frame: up to one year after TAAA repair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 30837256Petroff D, Czerny M, Kolbel T, Melissano G, Lonn L, Haunschild J, von Aspern K, Neuhaus P, Pelz J, Epstein DM, Romo-Aviles N, Piotrowski K, Etz CD. Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS(2)ACE): trial protocol for a randomised controlled multicentre trial. BMJ Open. 2019 Mar 4;9(3):e025488. doi: 10.1136/bmjopen-2018-025488.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian D Etz, Prof. Dr. principal investigator
University Leipzig
29 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally-Invasive Segmental Artery Coil-Embolization in people with Aortic Aneurysm, Thoracoabdominal, run by University of Leipzig at 29 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, Austria, France, Italy, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality. (time frame: 30 days after TAAA repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.