Brief Summary

TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other adjunctive medical devices.

The overarching purpose of this registry is to carry out a proactive gathering, recording, and analysis of data on the safety, performance and usability of the devices as applied within the routine practice of the participating registry sites.

Conditions

• Saccular and Fusiform Aneurysms
• Pseudoaneurysm
• Vascular Dissection
• Perforation
• Bifurcation Aneurysms
• Stenosis
• Neurovascular Abnormalties
• Wide-neck Aneurysm
• Intracranial Aneurysms

Intervention / Treatment

• Device: Aneurysm Treatment with a Neurovascular Flow Diverter
• Device: Dissection Treatment with a Neurovascular Flow Diverter
• Device: Perforation Treatment with a Neurovascular Flow Diverter
• Device: Arteriovenous Fistula treatment with a Neurovascular Flow Diverter
• Device: Aneurysm Treatment with Neurovascular Stent System
• Device: Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System
• Device: Dissection Treatment with Neurovascular Stent System
• Device: Aneurysm treatment with Bifurcation Aneurysm Implant
• Device: Aneurysm treatment with Avenir Coil System
• Device: Arteriovenous fistula treatment with Avenir Coil System

Primary Outcome Measures

• Morbi-mortality (Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites.)
  Morbi-mortality will be defined by a modified Rankin Scale (mRS) ≥ 3 in patients with an mRS ≤ 2 prior to the procedure, or at least 1-point increase over the initial mRS score in subjects with an mRS \> 2 prior to the procedure. The scale runs from 0-6 and is presented as below: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead

Countries

France, Germany, Italy, Slovakia, Switzerland

Locations and Investigators

• CHU Brest - Hôpital de La Cavale Blanche, Brest, France (Recruiting)
  • Jean-Christophe GENTRIC, Prof. Dr.
• Pitié Salpêtrière Hospital, Paris, France (Not yet recruiting)
  • Frédéric CLARENÇON, Prof. Dr.
• Helios Klinikum Erfurt, Erfurt, Germany (Not yet recruiting)
  • Joachim KLISCH, Prof.
• Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany (Not yet recruiting)
  • Maxim BESTER, PD. Dr.
• University Hospital Heidelberg, Heidelberg, Germany (Not yet recruiting)
  • Markus MÖHLENBRUCH, Prof.
• LMU Klinikum, München, Germany (Not yet recruiting)
  • Thomas LIEBIG, Prof. Dr.
• Klinikum Nürnberg, Nuremberg, Germany (Not yet recruiting)
  • Markus HOLTMANNSPÖTTER, Dr.
• Cannizzaro Hospital in Catania, Catania, Italy (Not yet recruiting)
  • Guglielmo PERO, Dr.
  • Concetto CRISTAUDO, Prof.
• ASST Grande Ospedale Metropolitano Niguarda, Milano, Milan, Italy (Not yet recruiting)
  • Mariangela PIANO, Dr.
• Antonio Cardarelli Hospital- Naples, Napoli, Italy (Not yet recruiting)
  • Mario MUTO, Prof.
  • Amedeo CERVO, Dr.
• Univerzitná nemocnica L. Pasteura Košice, Košice, Slovakia (Recruiting)
  • Piotr PEDOWSKI, Dr.
• Universitätsspital Basel, Basel, Switzerland (Not yet recruiting)
  • Marios-Nikos PSYCHOGIOS, Prof.
• Kantonsspital St.Gallen, Sankt Gallen, Switzerland (Not yet recruiting)
  • Victoria HELLSTERN, Dr.