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Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging (PAPA-ARTiS)

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ClinicalTrials.gov Identifier: NCT03434314
Recruitment Status : Not yet recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
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
Information provided by (Responsible Party):
Prof. Dr. Christian Etz, 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.


Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracoabdominal Procedure: Minimally-Invasive Segmental Artery Coil-Embolization Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPA-ARTiS
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MISACE arm

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
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.

No Intervention: control arm
receives treatment of aneurysm as usual: open surgical repair or endovascular repair without MISACE



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. substantial spinal cord injury [ Time Frame: 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. Normal

  2. 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 ]
    Spinal cord injury will be determined with a modified Tarlov scale (see above).

  3. mortality [ Time Frame: at 30 days and one year after TAAA repair ]
    all-cause mortality

  4. stay in intensive care unit and intermediate care [ Time Frame: 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

  5. sub-group analyses [ Time Frame: up to one year after TAAA repair ]
    sub-group analyses of spinal cord injury according to modified Tarlov scale (see above) for open repair and endovascular repair separately

  6. sub-group analyses [ Time Frame: up to one year after TAAA repair ]
    sub-group analyses of mortality for open repair and endovascular repair separately

  7. re-operation for bleeding [ Time Frame: from date of TAAA repair and up to one year after TAAA repair ]
    re-operation for bleeding (only for open repair)

  8. cross-clamping times [ Time Frame: during open surgery ]
    cross-clamping times during open surgery

  9. residual aneurysm sac perfusion [ Time Frame: up to one year after TAAA repair ]
    residual aneurysm sac perfusion, i.e. type II endoleaks (only for endovascular repair)

  10. costs [ Time Frame: up to one year after TAAA repair ]
    incremental cost-effectiveness ratio (ICER) will be calculated

  11. Quality Adjusted Life Years [ Time Frame: up to one year after TAAA repair ]
    Quality Adjusted Life Years (QALYs) will be estimated over one year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434314


Contacts
Contact: Christian D Etz, Prof. Dr. +49 341 865 251007 christian.etz@medizin.uni-leipzig.de
Contact: David Petroff, Dr. +49 341 97 16 354 david.petroff@zks.uni-leipzig.de

Locations
Austria
Medizinische Universität Innsbruck Not yet recruiting
Innsbruck, Austria
Contact: Michael Grimm, Prof. Dr.    +43 512 504 22500    michael.grimm@tirol-kliniken.at   
Contact: Johannes Holfeld, Dr.       johannes.holfeld@i-med.ac.at   
Herzzentrum Hietzing Not yet recruiting
Vienna, Austria
Contact: Martin Grabenwöger, Prof. Dr.    +43 1 4020585    Martin.Grabenwoeger@wienkav.at   
Contact: Gabriel Weiss, Dr.       gabriel.weiss@wienkav.at   
France
University Hospital of Bordeaux Not yet recruiting
Bordeaux, France
Contact: Eric Ducasse, Prof. Dr.    +335 56 79 55 25    eric.ducasse@chu-bordeaux.fr   
Marie Lannelongue Hospital Not yet recruiting
Le Plessis-Robinson, France
Contact: Stephan Haulon, Prof. Dr.         
Germany
Uniklinik RWTH Aachen Not yet recruiting
Aachen, Germany
Contact: Michael Jacobs, Prof. Dr.    +49 241 8085197    mjacobs@ukaachen.de   
Contact: Drosos Kotelis, Dr.       dkotelis@ukaachen.de   
Deutsches Herzzentrum Berlin Not yet recruiting
Berlin, Germany
Contact: Volkmar Falk, Prof. Dr.       falk@dhzb.de   
Contact: Semih Buz, Dr.       buz@dhzb.de   
Universitätsklinikum Düsseldorf Not yet recruiting
Düsseldorf, Germany
Contact: Hubert Schelzig, Prof. Dr.    0049 211 81 07211    hubert.schelzig@med.uni-duesseldorf.de   
Contact: Alexander Oberhuber, Dr.       Alexander.Oberhuber@med.uni-duesseldorf.de   
Westdeutsches Herz und Gefäßzentrum Essen Not yet recruiting
Essen, Germany
Contact: Heinz Jakob, Prof. Dr.    +49 201 723 4901    heinz.jakob@uk-essen.de   
Contact: Konstantinos Tsagakis, Dr.       Konstantinos.Tsagakis@uk-essen.de   
Universitäts-Herzzentrum Freiburg/ Bad Krozingen Not yet recruiting
Freiburg, Germany
Contact: Martin Czerny, Prof. Dr.    +49 7633 402 6216    martin.czerny@universitaets-herzzentrum.de   
Herzzentrum Hamburg Not yet recruiting
Hamburg, Germany
Contact: Tilo Kölbel, Prof. Dr.    +49 40 7410 58609    t.koelbel@uke.de   
Medizinische Hochschule Hannover Not yet recruiting
Hanover, Germany
Contact: Axel Haverich, Prof. Dr.    0049 511- 532 6580    haverich.axel@mh-hannover.de   
Contact: Malakh Shrestha, Prof. Dr.    0049 511- 532 6238    Shrestha.Malakh.lal@mh-hannover.de   
Universitätsklinikum Heidelberg Not yet recruiting
Heidelberg, Germany
Contact: Dittmar Böckler, Prof. Dr.    0049 6221 56 6249    dittmar.boeckler@med.uni-heidelberg.de   
Contact: Moritz Bischoff, Dr.       moritz.bischoff@med.uni-heidelberg.de   
Herzzentrum Leipzig Not yet recruiting
Leipzig, Germany
Contact: Christian D Etz, Prof. Dr.    +49 341 865 251007    christian.etz@medizin.uni-leipzig.de   
UniversitätskIinikum Leipzig Not yet recruiting
Leipzig, Germany
Contact: Scheinert Dierk, Prof.Dr.    +49 341 97 18770    dierk.scheinert@medizin.uni-leipzig.de   
Klinikum rechts der Isar (TU München) Not yet recruiting
Munich, Germany
Contact: Hans-Henning Eckstein, Prof. Dr.    +49 89 4140 9244    H.H.Eckstein@lrz.tum.de   
Contact: Sarah Geisbüsch, Dr.       sarah.geisbuesch@mri.tum.de   
Klinikum der Universität München (LMU) Not yet recruiting
München, Germany
Contact: Maximilian Luehr, Dr.    + 49 89 4400 72436    maximilian.luehr@med.uni-muenchen.de   
St. Franziskus-Hospital GmbH Not yet recruiting
Münster, Germany
Contact: Giovanni Torsello, Prof. Dr.    0049 251 935-3933    giovanni.torsello@ukmuenster.de   
Contact: Theodosios Bisdas, Dr.       theodosios.bisdas@sfh-muenster.de   
Paracelsus Universität - Klinikum Nürnberg Not yet recruiting
Nuremberg, Germany
Contact: Eric Verhoeven, Prof. Dr.    0049 911 398 117004    eric.verhoeven@klinikum-nuernberg.de   
Contact: Athanasios Katsargyris, Dr.       Athanasios.Katsargyris@klinikum-nuernberg.de   
Universitätsklinikum Regensburg Not yet recruiting
Regensburg, Germany
Contact: Karin Pfister, Prof. Dr.    +49 941 944 6911    Karin.Pfister@klinik.uni-regensburg.de   
Contact: Piotr Kasprzak, Prof. Dr.       piotr.kasprzak@ukr.de   
Universitätsklinikum Tübingen Not yet recruiting
Tübingen, Germany
Contact: Christian Schlensak, Prof. Dr.    0049 7071 29 86638    christian.schlensak@med.uni-tuebingen.de   
Contact: Mario Lescan, Dr.       mario.lescan@med.uni-tuebingen.de   
Italy
S.Orsola-Malpighi Hospital Not yet recruiting
Bologna, Italy
Contact: Davide Pacini, Prof. Dr.    +39 051 6363329    davide.pacini@unibo.it   
Ospedale San Raffaele SRL Not yet recruiting
Milano, Italy
Contact: Roberto Chiesa, Prof. Dr.    +39 02 2643 7148    chiesa.roberto@unisr.it   
Contact: Germano Melissano, Prof. Dr.    +39 02 2643 7148    melissano.germano@hsr.it   
Netherlands
Maastricht University Medical Center Not yet recruiting
Maastricht, Netherlands
Contact: Michael Jacobs, Prof. Dr.       m.jacobs@mumc.nl   
Contact: Barend Mees, Dr.    +31 43 3877478    barend.mees@mumc.nl   
Poland
Medical University of Warsaw Not yet recruiting
Warsaw, Poland
Contact: Tomasz Jakimowicz, Dr.       tomj@wum.edu.pl   
Silesian Center for Heart Diseases Not yet recruiting
Zabrze, Poland
Contact: Marian Zembala, Prof. Dr.    +48 323733689    m.zembala@sccs.pl; sek.kch@sccs.pl   
Contact: Maciej K Kolowca, Dr.       maciej@kolowca.eu   
Sweden
Lund University Hospital Malmoe Not yet recruiting
Malmö, Sweden
Contact: Tim Resch, Dr.       tim.resch@med.lu.se   
Örebro University Hospital Not yet recruiting
Örebro, Sweden
Contact: Thomas Larzon, Prof. Dr.       thomas.larzon@regionorebrolan.se   
Switzerland
Bern University Hospital Not yet recruiting
Bern, Switzerland
Contact: Jürg Schmidli, Prof. Dr.    +41 31 632 26 02    juerg.schmidli@insel.ch   
United Kingdom
St Bartholomews Hospital Not yet recruiting
London, United Kingdom
Contact: Aung Y Oo, Prof. Dr.       AungYe.OO@Bartshealth.nhs.uk   
Sponsors and Collaborators
University of Leipzig
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
Investigators
Principal Investigator: Christian D Etz, Prof. Dr. University Leipzig

Responsible Party: Prof. Dr. Christian Etz, University of Leipzig
ClinicalTrials.gov Identifier: NCT03434314     History of Changes
Other Study ID Numbers: 1.0
733203 ( Other Grant/Funding Number: Horizon2020, European Commission )
ET 127/2-1 ( Other Grant/Funding Number: German Research Foundation )
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Christian Etz, University of Leipzig:
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

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Paraplegia
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms