Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging

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

Interventions

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.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• German Research Foundation

  collaborator OTHER

• Universidad de Granada

  collaborator OTHER

• European Clinical Research Infrastructure Network

  collaborator OTHER

• Modus Research and Innovation Limited

  collaborator UNKNOWN

• Rigshospitalet, Denmark

  collaborator OTHER

• European Society of Cardiology

  collaborator NETWORK

• Baylor College of Medicine

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Leipzig

  lead OTHER

Principal Investigators

• Christian D Etz, Prof. Dr. · University Leipzig

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-08

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

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

Study Locations