Targeting Real World Usage In Stroke Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Aneurysm Treatment with a Neurovascular Flow Diverter: Treatment of aneurysms (saccular or fusiform) and pseudoaneurysms with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.

Dissection Treatment with a Neurovascular Flow Diverter: Treatment of vascular dissections in the acute and chronic phases with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.

Perforation Treatment with a Neurovascular Flow Diverter: Treatment of vascular perforations with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.

Arteriovenous Fistula treatment with a Neurovascular Flow Diverter: Treatment of Arteriovenous fistula with a Neurovascular Flow Diverter. This includes p64, p64 MW, p64 MW HPC, p48 MW and p48 MW HPC.

Aneurysm Treatment with Neurovascular Stent System: Treatment of saccular and fusiform aneurysms as well as pseudoaneurysms with pEGASUS HPC. pEGASUS HPC is to be used in combination with coils.

Atherosclerotic vascular stenosis Treatment with Neurovascular Stent System: Atherosclerotic vascular stenosis of intracranial arteries treated with pEGASUS HPC.

Dissection Treatment with Neurovascular Stent System: Treatment of vascular dissections in the acute and chronic phases with pEGASUS HPC.

Aneurysm treatment with Bifurcation Aneurysm Implant: Treatment of intracranial bifurcation aneurysms with pCONUS 2 or pCONUS 2 HPC.

Aneurysm treatment with Avenir Coil System: Treatment of intracranial aneurysms with the available variants of the Avenir Coil System.

Arteriovenous fistula treatment with Avenir Coil System: Treatment of arteriovenous fistula with the available variants of the Avenir Coil System.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (13)