NCT02988128

Neurovascular Product Surveillance Registry

NeuroVascular Product Surveillance Registry (PSR) Platform

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Post market surveillance registry

Detailed description

An observational, prospective, multi-center, single-arm registry to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic Stroke. MDT16056 and MDT17077 are conducted under the Product Surveillance Registry (NCT01524276).

Conditions

• Intracranial Aneurysm
• Stroke, Ischemic

Interventions

Type	Name	Description
DEVICE	Treatment for intracranial aneurysms	Embolization of aneurysms
DEVICE	Treatment for Acute Ischemic Stroke	Revascularization of an intracranial blood vessel

Timeline

• Start date: 2016-12-01
• Primary completion: 2032-08-01
• Completion: 2032-08-01
• First posted: 2016-12-09
• Last updated: 2025-12-24

Locations

99 sites across 24 countries: Argentina, Australia, Austria, Belgium, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Poland, Portugal, Russia, Slovakia, South Africa, South Korea, Spain, Switzerland, United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated device study