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

April 9, 2024 updated by: David Petroff, University of Leipzig

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria
        • Medizinische Universitat Innsbruck
      • Vienna, Austria
        • Herzzentrum Hietzing
  • France
      • Bordeaux, France
        • University Hospital of Bordeaux
      • Le Plessis-Robinson, France
        • Marie Lannelongue Hospital
  • Germany
      • Aachen, Germany
        • Uniklinik RWTH Aachen
      • Berlin, Germany
        • Deutsches Herzzentrum Berlin
      • Düsseldorf, Germany
        • Universitatsklinikum Dusseldorf
      • Essen, Germany
        • Westdeutsches Herz und Gefäßzentrum Essen
      • Freiburg, Germany
        • Universitäts-Herzzentrum Freiburg/ Bad Krozingen
      • Hamburg, Germany
        • Herzzentrum Hamburg
      • Hanover, Germany
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • UniversitatsKlinikum Heidelberg
      • Leipzig, Germany
        • Herzzentrum Leipzig
      • Leipzig, Germany
        • UniversitätskIinikum Leipzig
      • Munich, Germany
        • Klinikum rechts der Isar (TU München)
      • München, Germany
        • Klinikum der Universität München (LMU)
      • Münster, Germany
        • Universitatsklinikum Munster
      • Nuremberg, Germany
        • Paracelsus Universität - Klinikum Nürnberg
      • Regensburg, Germany
        • Universitätsklinikum Regensburg
      • Tübingen, Germany
        • Universitatsklinikum Tubingen
  • Italy
      • Bologna, Italy
        • S.Orsola-Malpighi Hospital
      • Milano, Italy
        • Ospedale San Raffaele SRL
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center
  • Poland
      • Warsaw, Poland
        • Medical University of Warsaw
      • Zabrze, Poland
        • Silesian Center for Heart Diseases
  • Sweden
      • Malmö, Sweden
        • Lund University Hospital Malmoe
      • Örebro, Sweden
        • Orebro University Hospital
  • Switzerland
      • Bern, Switzerland
        • Bern University Hospital
  • United Kingdom
      • London, United Kingdom
        • St Bartholomews Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
30 days after TAAA repair

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Spinal cord injury will be determined with a modified Tarlov scale (see above).
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
all-cause mortality
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
length of stay in intensive care unit and intermediate care unit after TAAA repair
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 of spinal cord injury according to modified Tarlov scale (see above) for open repair and endovascular repair separately
up to one year after TAAA repair
sub-group analyses
Time Frame: up to one year after TAAA repair
sub-group analyses of mortality for open repair and endovascular repair separately
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
re-operation for bleeding (only for open repair)
from date of TAAA repair and up to one year after TAAA repair
cross-clamping times
Time Frame: during open surgery
cross-clamping times during open surgery
during open surgery
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)
up to one year after TAAA repair
costs
Time Frame: up to one year after TAAA repair
incremental cost-effectiveness ratio (ICER) will be calculated
up to one year after TAAA repair
Quality Adjusted Life Years
Time Frame: up to one year after TAAA repair
Quality Adjusted Life Years (QALYs) will be estimated over one year
up to one year after TAAA repair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leipzig

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Research Foundation
Baylor College of Medicine
University of Pennsylvania
Rigshospitalet, Denmark
Universidad de Granada
European Commission
European Society of Cardiology
European Clinical Research Infrastructure Network
Modus Research and Innovation Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian D Etz, Prof. Dr., University Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAPAartis
  • 733203 (Other Grant/Funding Number: Horizon2020, European Commission)
  • ET 127/2-1 (Other Grant/Funding Number: German Research Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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