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Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging (PAPAartis)

Primary Purpose

Aortic Aneurysm, Thoracoabdominal

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Minimally-Invasive Segmental Artery Coil-Embolization
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Thoracoabdominal focused on measuring 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, TEVAR, Aortic surgery, Thoracoabdominal aortic surgery, Type B aortic dissection, Chronic type B aortic dissection, Stanford type B aortic dissection, Collateral network, Paraspinal collateral network, Paraspinous collateral network, Arteriogenesis, Intercostal arteries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Universität Innsbruck
  • Herzzentrum Hietzing
  • University Hospital of Bordeaux
  • Marie Lannelongue Hospital
  • Uniklinik RWTH Aachen
  • Deutsches Herzzentrum Berlin
  • Universitätsklinikum Düsseldorf
  • Westdeutsches Herz und Gefäßzentrum Essen
  • Universitäts-Herzzentrum Freiburg/ Bad KrozingenRecruiting
  • Herzzentrum HamburgRecruiting
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg
  • Herzzentrum LeipzigRecruiting
  • UniversitätskIinikum LeipzigRecruiting
  • Klinikum rechts der Isar (TU München)Recruiting
  • Klinikum der Universität München (LMU)
  • Universitätsklinikum Münster
  • Paracelsus Universität - Klinikum Nürnberg
  • Universitätsklinikum Regensburg
  • Universitätsklinikum Tübingen
  • S.Orsola-Malpighi Hospital
  • Ospedale San Raffaele SRL
  • Maastricht University Medical Center
  • Medical University of Warsaw
  • Silesian Center for Heart Diseases
  • Lund University Hospital Malmoe
  • Örebro University Hospital
  • Bern University Hospital
  • St Bartholomews Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MISACE arm

control arm

Arm Description

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 treatment of aneurysm as usual: open surgical repair or endovascular repair without MISACE

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

substantial spinal cord injury
Substantial spinal cord injury is defined as zero to two on the modified Tarlov scale. 0. 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
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).
mortality
all-cause mortality
stay in intensive care unit and intermediate care
length of stay in intensive care unit and intermediate care unit 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
sub-group analyses
sub-group analyses of mortality for open repair and endovascular repair separately
re-operation for bleeding
re-operation for bleeding (only for open repair)
cross-clamping times
cross-clamping times during open surgery
residual aneurysm sac perfusion
residual aneurysm sac perfusion, i.e. type II endoleaks (only for endovascular repair)
costs
incremental cost-effectiveness ratio (ICER) will be calculated
Quality Adjusted Life Years
Quality Adjusted Life Years (QALYs) will be estimated over one year

Full Information

First Posted
January 12, 2018
Last Updated
November 4, 2022
Sponsor
University of Leipzig
Collaborators
European Commission, German Research Foundation, Universidad de Granada, European Clinical Research Infrastructure Network, Modus Research and Innovation Limited, Rigshospitalet, Denmark, European Society of Cardiology, Baylor College of Medicine, University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03434314
Brief Title
Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging
Acronym
PAPAartis
Official Title
Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPAartis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
European Commission, German Research Foundation, Universidad de Granada, European Clinical Research Infrastructure Network, Modus Research and Innovation Limited, Rigshospitalet, Denmark, European Society of Cardiology, Baylor College of Medicine, University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracoabdominal
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, TEVAR, Aortic surgery, Thoracoabdominal aortic surgery, Type B aortic dissection, Chronic type B aortic dissection, Stanford type B aortic dissection, Collateral network, Paraspinal collateral network, Paraspinous collateral network, Arteriogenesis, Intercostal arteries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MISACE arm
Arm Type
Experimental
Arm Description
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)
Arm Title
control arm
Arm Type
No Intervention
Arm Description
receives treatment of aneurysm as usual: open surgical repair or endovascular repair without MISACE
Intervention Type
Procedure
Intervention Name(s)
Minimally-Invasive Segmental Artery Coil-Embolization
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality.
Description
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
Secondary Outcome Measure Information:
Title
substantial spinal cord injury
Description
Substantial spinal cord injury is defined as zero to two on the modified Tarlov scale. 0. 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
Time Frame
30 days after TAAA repair and at one year after TAAA repair
Title
spinal cord injury according to the modified Tarlov scale from TAAA repair to one year
Description
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
Title
mortality
Description
all-cause mortality
Time Frame
at 30 days and one year after TAAA repair
Title
stay in intensive care unit and intermediate care
Description
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
Title
sub-group analyses
Description
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
Title
sub-group analyses
Description
sub-group analyses of mortality for open repair and endovascular repair separately
Time Frame
up to one year after TAAA repair
Title
re-operation for bleeding
Description
re-operation for bleeding (only for open repair)
Time Frame
from date of TAAA repair and up to one year after TAAA repair
Title
cross-clamping times
Description
cross-clamping times during open surgery
Time Frame
during open surgery
Title
residual aneurysm sac perfusion
Description
residual aneurysm sac perfusion, i.e. type II endoleaks (only for endovascular repair)
Time Frame
up to one year after TAAA repair
Title
costs
Description
incremental cost-effectiveness ratio (ICER) will be calculated
Time Frame
up to one year after TAAA repair
Title
Quality Adjusted Life Years
Description
Quality Adjusted Life Years (QALYs) will be estimated over one year
Time Frame
up to one year after TAAA repair

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian D Etz, Prof. Dr.
Phone
+49 341 865 251007
Email
christian.etz@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
David Petroff, Dr.
Phone
+49 341 97 16 354
Email
david.petroff@zks.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian D Etz, Prof. Dr.
Organizational Affiliation
University Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
Herzzentrum Hietzing
City
Vienna
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Grabenwöger, Prof. Dr.
Phone
+43 1 4020585
Email
Martin.Grabenwoeger@wienkav.at
First Name & Middle Initial & Last Name & Degree
Gabriel Weiss, Dr.
Email
gabriel.weiss@wienkav.at
Facility Name
University Hospital of Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Ducasse, Prof. Dr.
Phone
+335 56 79 55 25
Email
eric.ducasse@chu-bordeaux.fr
Facility Name
Marie Lannelongue Hospital
City
Le Plessis-Robinson
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Haulon, Prof. Dr.
Email
s.haulon@hml.fr
Facility Name
Uniklinik RWTH Aachen
City
Aachen
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volkmar Falk, Prof. Dr.
Email
falk@dhzb.de
First Name & Middle Initial & Last Name & Degree
Semih Buz, Dr.
Email
buz@dhzb.de
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Westdeutsches Herz und Gefäßzentrum Essen
City
Essen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heinz Jakob, Prof. Dr.
Phone
+49 201 723 4901
Email
heinz.jakob@uk-essen.de
First Name & Middle Initial & Last Name & Degree
Konstantinos Tsagakis, Dr.
Email
Konstantinos.Tsagakis@uk-essen.de
Facility Name
Universitäts-Herzzentrum Freiburg/ Bad Krozingen
City
Freiburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Czerny, Prof. Dr.
Phone
+49 7633 402 6216
Email
martin.czerny@universitaets-herzzentrum.de
Facility Name
Herzzentrum Hamburg
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tilo Kölbel, Prof. Dr.
Phone
+49 40 7410 58609
Email
t.koelbel@uke.de
Facility Name
Medizinische Hochschule Hannover
City
Hanover
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Haverich, Prof. Dr.
Phone
0049 511- 532 6580
Email
haverich.axel@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Malakh Shrestha, Prof. Dr.
Phone
0049 511- 532 6238
Email
Shrestha.Malakh.lal@mh-hannover.de
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Herzzentrum Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian D Etz, Prof. Dr.
Phone
+49 341 865 251007
Email
christian.etz@medizin.uni-leipzig.de
Facility Name
UniversitätskIinikum Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scheinert Dierk, Prof.Dr.
Phone
+49 341 97 18770
Email
dierk.scheinert@medizin.uni-leipzig.de
Facility Name
Klinikum rechts der Isar (TU München)
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Henning Eckstein, Prof. Dr.
Phone
+49 89 4140 9244
Email
H.H.Eckstein@lrz.tum.de
First Name & Middle Initial & Last Name & Degree
Matthias Trenner, Dr.
Phone
+49 89 4140 5065
Email
Matthias.Trenner@mri.tum.de
Facility Name
Klinikum der Universität München (LMU)
City
München
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Paracelsus Universität - Klinikum Nürnberg
City
Nuremberg
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Schlensak, Prof. Dr.
Phone
0049 7071 29 86638
Email
christian.schlensak@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Mario Lescan, Dr.
Email
mario.lescan@med.uni-tuebingen.de
Facility Name
S.Orsola-Malpighi Hospital
City
Bologna
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Pacini, Prof. Dr.
Phone
+39 051 6363329
Email
davide.pacini@unibo.it
Facility Name
Ospedale San Raffaele SRL
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Chiesa, Prof. Dr.
Phone
+39 02 2643 7148
Email
chiesa.roberto@unisr.it
First Name & Middle Initial & Last Name & Degree
Germano Melissano, Prof. Dr.
Phone
+39 02 2643 7148
Email
melissano.germano@hsr.it
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Jacobs, Prof. Dr.
Email
m.jacobs@mumc.nl
First Name & Middle Initial & Last Name & Degree
Barend Mees, Dr.
Phone
+31 43 3877478
Email
barend.mees@mumc.nl
Facility Name
Medical University of Warsaw
City
Warsaw
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Jakimowicz, Dr.
Email
tomj@wum.edu.pl
Facility Name
Silesian Center for Heart Diseases
City
Zabrze
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marian Zembala, Prof. Dr.
Phone
+48 323733689
Email
m.zembala@sccs.pl; sek.kch@sccs.pl
First Name & Middle Initial & Last Name & Degree
Maciej K Kolowca, Dr.
Email
maciej@kolowca.eu
Facility Name
Lund University Hospital Malmoe
City
Malmö
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Resch, Dr.
Email
tim.resch@med.lu.se
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Larzon, Prof. Dr.
Email
thomas.larzon@regionorebrolan.se
Facility Name
Bern University Hospital
City
Bern
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürg Schmidli, Prof. Dr.
Phone
+41 31 632 26 02
Email
juerg.schmidli@insel.ch
Facility Name
St Bartholomews Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aung Y Oo, Prof. Dr.
Email
AungYe.OO@Bartshealth.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30837256
Citation
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.
Results Reference
derived

Learn more about this trial

Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging

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