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Neurovascular Product Surveillance Registry (INSPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02988128
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Brief Summary:
Post market surveillance registry

Condition or disease Intervention/treatment
Intracranial Aneurysm Stroke, Ischemic Device: Treatment for intracranial aneurysms Device: Treatment for Acute Ischemic Stroke

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: NeuroVascular Product Surveillance Registry (PSR) Platform
Study Start Date : December 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Treatment for intracranial aneurysms
    Embolization of aneurysms
  • Device: Treatment for Acute Ischemic Stroke
    Revascularization of a large vessel


Primary Outcome Measures :
  1. The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%). [ Time Frame: 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%).

  2. Functional Independence: mRS score ≤ 2 [ Time Frame: 90 days ]
    For Acute ischemic stroke the primary outcome is functional Independence: mRS score ≤ 2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Intracranial aneurysms: Patients requiring treatment for intracranial aneurysms with market approved Medtronic flow diverters, intrasaccular devices or vascular reconstruction devices are eligible for the registry.

Acute Ischemic Stroke: Patients requiring treatment for Large Vessel Occlusion Acute Ischemic Stroke with Medtronic market approved aspiration and/or revascularization devices are eligible for the study.

Criteria

Inclusion Criteria:

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive or be treated with an eligible product
  • Patient within enrollment window of treatment/therapy received at the time of their initial 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988128


Contacts
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Contact: Simone Minozzo +31615965903 simone.minozzo@medtronic.com
Contact: Wouter Fabry +32496165078 wouter.fabry@medtronic.com

Locations
Show Show 42 study locations
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Medtronic Bakken Research Center
Investigators
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Study Chair: Markus Holtmannspotter, MD Klinikum Nürnberg Süd
Study Chair: Laurent Spelle, MD Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique
Study Chair: Jens Fiehler, MD Universitätsklinikum Hamburg-Eppendorf
Study Chair: István Szikora, MD National Institute of Clinical Neurosciences
Study Chair: Mario Galdamez, MD Hospital Clínico Universitario de Valladolid
Study Chair: Saleh Lamin, MD Queen Elisabeth Hospital, Neuroradiology
Study Chair: Francis Turjman, MD Hôpital Pierre Wertheimer
Study Chair: Christophe Cognard, MD CHU Toulouse - Hôpital Purpan
Study Chair: Markus Möhlenbruch, MD University Hospital Heidelberg
Study Chair: Marc Ribó, MD Hospital Vall d'Hebron
Study Chair: Pasquale Mordasini, MD Inselspital - Universitätsspital Bern
Study Chair: Michel Mawad, MD LAU Medical Center-Rizk Hospital
Additional Information:

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02988128    
Other Study ID Numbers: MDT16056/MDT17077
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only multi center data will be available
Keywords provided by Medtronic Neurovascular Clinical Affairs:
Embolization Device
Flow Diverter
Intra saccular device
Vascular Reconstruction Device
Ruptured Intracranial Aneurysm
Unruptured Intracranial Aneurysm
Large Vessel Occlusion
Stent Retriever
Aspiration Catheter
Revascularization Device
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases