Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging

NCT03434314 | Active Not Recruiting DMC

• 3 other identifiers: PAPAartis733203ET 127/2-1
• Study Type: interventional
• Target: 500
• Locations: 9 countries
• Sites: 29

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  30 days after TAAA repair

Secondary Outcomes (11)

• substantial spinal cord injury

  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

  from date of TAAA repair and up to one year after TAAA repair

• mortality

  at 30 days and one year after TAAA repair

• stay in intensive care unit and intermediate care

  from date of TAAA repair and up to one year after TAAA repair

• sub-group analyses

  up to one year after TAAA repair

Study Arms (2)

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)

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

Interventions

Minimally-Invasive Segmental Artery Coil-Embolization PROCEDURE

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.

MISACE arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TAAA, Crawford type II or III
• planned open or endovascular repair of aneurysm within four months
• ≥ 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead
• European Commission: collaborator
• German Research Foundation: collaborator
• Universidad de Granada: collaborator
• European Clinical Research Infrastructure Network: collaborator
• Modus Research and Innovation Limited: collaborator
• Rigshospitalet, Denmark: collaborator
• European Society of Cardiology: collaborator
• Baylor College of Medicine: collaborator
• University of Pennsylvania: collaborator

Study Sites (29)

Medizinische Universität Innsbruck

Innsbruck, Austria

Location

Herzzentrum Hietzing

Vienna, Austria

Location

University Hospital of Bordeaux

Bordeaux, France

Location

Marie Lannelongue Hospital

Le Plessis-Robinson, France

Location

Uniklinik RWTH Aachen

Aachen, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Westdeutsches Herz und Gefäßzentrum Essen

Essen, Germany

Location

Universitäts-Herzzentrum Freiburg/ Bad Krozingen

Freiburg im Breisgau, Germany

Location

Herzzentrum Hamburg

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

UniversitätskIinikum Leipzig

Leipzig, Germany

Location

Klinikum rechts der Isar (TU München)

Munich, Germany

Location

Klinikum der Universität München (LMU)

München, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Paracelsus Universität - Klinikum Nürnberg

Nuremberg, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

S.Orsola-Malpighi Hospital

Bologna, Italy

Location

Ospedale San Raffaele SRL

Milan, Italy

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Medical University of Warsaw

Warsaw, Poland

Location

Silesian Center for Heart Diseases

Zabrze, Poland

Location

Lund University Hospital Malmoe

Malmo, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Bern University Hospital

Bern, Switzerland

Location

St Bartholomews Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30837256 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Paraplegia; Spinal Cord Ischemia; Spinal Cord Injuries; Paraparesis

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Vascular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paresis

Study Officials

• Christian D Etz, Prof. Dr.

  University Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. David Petroff [Prof. Dr. Christian Etz]

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 15, 2018
• Study Start: November 8, 2018
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

FR (2); PL (2); AU (2); SE (2); IT (2); DE (16); NL (1); CH (1); GB (1)