Neurovascular Product Surveillance Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Neurovascular Clinical Affairs
About this trial
Post market surveillance registry
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Intracranial aneurysms: Patients requiring treatment for intracranial aneurysms with Medtronic market-approved flow diverters, intrasaccular devices, vascular reconstruction devices and/or ancillary devices are eligible for the registry. Acute Ischemic Stroke: Patients requiring treatment with Medtronic market approved stent retrievers and/or aspiration devices, and/or ancillary devices for the treatment of acute ischemic stroke due to intracranial vessel occlusion are eligible for enrollment in the registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Treatment for intracranial aneurysms
DeviceEmbolization of aneurysms
Treatment for Acute Ischemic Stroke
DeviceRevascularization of an intracranial blood vessel
Treatment groups
4,000 Participants
are divided into 2 treatment groupsGroup A: Intracranial aneurysm1 intervention
Group B: Acute Ischemic Stroke1 intervention
Trial outcomes
Primary outcomes
1
The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
Time frame
1 year2
Functional Independence: mRS score ≤ 2
For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medtronic Neurovascular Clinical Affairs
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborator
Source ClinicalTrials.gov