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Neurovascular Product Surveillance Registry

Sponsor: Medtronic Neurovascular Clinical Affairs

NCT ID: NCT02988128

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Treatment for intracranial aneurysms (device), Treatment for Acute Ischemic Stroke (device)
How long the study runs
Study runs about 188 months (dates as stated)
About the drug or intervention
Treatment for intracranial aneurysms — device: Embolization of aneurysms · Treatment for Acute Ischemic Stroke — device: Revascularization of an intracranial blood vessel
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
4,000
Started
2016-12
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for intracranial aneurysm
  • • Clinical study - 4,000 participants
  • • Post market surveillance registry

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with intracranial aneurysm

Where?

  • • Birmingham - University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
  • • Edinburgh - Royal Infirmary of Edinburgh
  • • London - Imperial College Healthcare NHS Trust - Charing Cross Hospital
  • • Romford - Barking, Havering and Redbridge University Hospitals - Queen's Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Post market surveillance registry

More detail

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).

Intracranial AneurysmStroke, Ischemic

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and...
  • ✓Patient has, or is intended to receive or be treated with, an eligible Medtronic product
  • ✓Patient is consented within the enrollment window of the therapy received, as applicable
  • ✓Patient is at least 18 years of age at time of enrollment.

Who cannot take part

  • ✗Patient who is, or is expected to be inaccessible for follow-up
  • ✗Patient with exclusion criteria required by local law
  • ✗Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
  • ✗Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in...
  • ✗For MDT24028 and MDT22032:
See the full criteria
For MDT16056 and MDT17077 Inclusion Criteria: * Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements * Patient has, or is intended to receive or be treated with, an eligible Medtronic product * Patient is consented within the enrollment window of the therapy received, as applicable * Patient is at least 18 years of age at time of enrollment. Exclusion Criteria: * Patient who is, or is expected to be inaccessible for follow-up * Patient with exclusion criteria required by local law * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results * Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. For MDT24028 and MDT22032: General Inclusion Criteria: * Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements. * Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product. * Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template General Exclusion Criteria: * Patient who may be unable to complete the study follow-up * Patient with any contraindications per the applicable Instructions for Use document * Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study * Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results. Additional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.

Where Is This Study? (5 UK sites)

University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Royal Infirmary of Edinburgh

Edinburgh EH16 4SA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Imperial College Healthcare NHS Trust - Charing Cross Hospital

London W6 8RF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Barking, Havering and Redbridge University Hospitals - Queen's Hospital

Romford, United Kingdom

Recruiting
Hospital R&D contact (matched)

Heidi Chandler

bhrut.development.research@nhs.net01708 435000 ex 2923

University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385

How to Get in Touch

Wouter Fabry

Sponsor contact

CONTACT

+32496165078 wouter.fabry@medtronic.com

Beatrice Carlotta Sicurella

Sponsor contact

CONTACT

+390224137264 beatrice.carlotta.sicurella@medtronic.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09