NCT02988128 Neurovascular Product Surveillance Registry
| NCT ID | NCT02988128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Neurovascular Clinical Affairs |
| Condition | Intracranial Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2016-12 |
| Primary Completion | 2032-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2016-12 with a primary completion date of 2032-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post market surveillance registry
Eligibility 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.
Contact & Investigator
Markus Holtmannspotter, MD
STUDY CHAIR
Klinikum Nürnberg Süd
Frequently Asked Questions
Who can join the NCT02988128 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02988128 currently recruiting?
Yes, NCT02988128 is actively recruiting participants. Contact the research team at wouter.fabry@medtronic.com for enrollment information.
Where is the NCT02988128 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, Southport, Australia, Salzburg, Austria, Genk, Belgium and 11 additional locations.
Who is sponsoring the NCT02988128 clinical trial?
NCT02988128 is sponsored by Medtronic Neurovascular Clinical Affairs. The principal investigator is Markus Holtmannspotter, MD at Klinikum Nürnberg Süd. The trial plans to enroll 4,000 participants.