Intracranial Aneurysm, Stroke, Ischemic
Conditions
Keywords
Embolization Device, Flow Diverter, Intrasaccular device, Vascular Reconstruction Device, Ruptured Intracranial Aneurysm, Unruptured Intracranial Aneurysm, Large Vessel Occlusion, Stent Retriever, Aspiration Catheter, Revascularization Device
Brief 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).
Interventions
DEVICETreatment for intracranial aneurysms
Embolization of aneurysms
DEVICETreatment for Acute Ischemic Stroke
Revascularization of an intracranial blood vessel
Sponsors
Medtronic Neurovascular Clinical Affairs
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%). | 1 year | 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%). |
| Functional Independence: mRS score ≤ 2 | 90 days | For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2 |
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
Contacts
CONTACTWouter Fabry
CONTACTBeatrice Carlotta Sicurella
STUDY_CHAIRMarkus Holtmannspotter, MD
Klinikum Nürnberg Süd
STUDY_CHAIRLaurent Spelle, MD
Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique
STUDY_CHAIRJens Fiehler, MD
Universitätsklinikum Hamburg-Eppendorf
STUDY_CHAIRIstván Szikora, MD
National Institute of Clinical Neurosciences
STUDY_CHAIRMario Galdamez, MD
Hospital Clínico Universitario de Valladolid
STUDY_CHAIRSaleh Lamin, MD
Queen Elisabeth Hospital, Neuroradiology
STUDY_CHAIRFrancis Turjman, MD
Hôpital Pierre Wertheimer
STUDY_CHAIRChristophe Cognard, MD
CHU Toulouse - Hôpital Purpan
STUDY_CHAIRMarkus Möhlenbruch, MD
University Hospital Heidelberg
STUDY_CHAIRMarc Ribó, MD
Hospital Vall d'Hebron
STUDY_CHAIRPasquale Mordasini, MD
Inselspital - Universitätsspital Bern
STUDY_CHAIRSanjeev Nayak, MD
University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
STUDY_CHAIRRiitta Rautio, MD
Turun Yliopistollinen keskussairaala
STUDY_CHAIRMonika Killer-Oberpfalzer, MD
Universitätsklinikum Christian Doppler Klinik Salzburg
Outcome results
None listed