Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging

NCT ID: NCT03434314

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-08
• Study Completion Date: 2025-06-30

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.

Conditions

Aortic Aneurysm, Thoracoabdominal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Minimally-Invasive Segmental Artery Coil-Embolization

Intervention Type: 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.

control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

German Research Foundation

OTHER

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: collaborator

European Clinical Research Infrastructure Network

OTHER

Sponsor Role: collaborator

Modus Research and Innovation Limited

UNKNOWN

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

European Society of Cardiology

NETWORK

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

David Petroff

Dr. David Petroff [Prof. Dr. Christian Etz]

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian D Etz, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Leipzig

Locations

Medizinische Universität Innsbruck

Innsbruck, , Austria

Herzzentrum Hietzing

Vienna, , Austria

University Hospital of Bordeaux

Bordeaux, , France

Marie Lannelongue Hospital

Le Plessis-Robinson, , France

Uniklinik RWTH Aachen

Aachen, , Germany

Deutsches Herzzentrum Berlin

Berlin, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Westdeutsches Herz und Gefäßzentrum Essen

Essen, , Germany

Universitäts-Herzzentrum Freiburg/ Bad Krozingen

Freiburg im Breisgau, , Germany

Herzzentrum Hamburg

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Herzzentrum Leipzig

Leipzig, , Germany

UniversitätskIinikum Leipzig

Leipzig, , Germany

Klinikum rechts der Isar (TU München)

Munich, , Germany

Klinikum der Universität München (LMU)

München, , Germany

Universitätsklinikum Münster

Münster, , Germany

Paracelsus Universität - Klinikum Nürnberg

Nuremberg, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

S.Orsola-Malpighi Hospital

Bologna, , Italy

Ospedale San Raffaele SRL

Milan, , Italy

Maastricht University Medical Center

Maastricht, , Netherlands

Medical University of Warsaw

Warsaw, , Poland

Silesian Center for Heart Diseases

Zabrze, , Poland

Lund University Hospital Malmoe

Malmo, , Sweden

Örebro University Hospital

Örebro, , Sweden

Bern University Hospital

Bern, , Switzerland

St Bartholomews Hospital

London, , United Kingdom

Countries

Austria; France; Germany; Italy; Netherlands; Poland; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30837256 (View on PubMed)

Other Identifiers

733203

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ET 127/2-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PAPAartis

Identifier Type: -

Identifier Source: org_study_id