Viewing Study NCT05213533


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Study NCT ID: NCT05213533
Status: UNKNOWN
Last Update Posted: 2022-02-11
First Post: 2022-01-16
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Kanagawa Intravenous and Endvascular Treatment Registry
Sponsor: St. Marianna University Toyoko Hospital
Organization:

Study Overview

Official Title: Kanagawa Intravenous and Endovascular Treatment Registry for Acute Ischemic Stroke
Status: UNKNOWN
Status Verified Date: 2022-01
Last Known Status: ENROLLING_BY_INVITATION
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: K-NET
Brief Summary: The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. This study is attended by 40 of the 58 Primary Stroke Centers in Kanagawa Prefecture, which is located in the Tokyo metropolitan area and has a population of 9.24 million. Patient enrollment for this study began in January 2018.
Detailed Description: Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion. There were no exclusion criteria. The local neurologists, neurosurgeons, and neurointerventionalists at each institution made the decision to perform EVT and intravenous tPA.

The primary outcome was good as defined by the modified Rankin Scale (mRS) of 0 to 2 at three months. We also determined a favorable outcome: mRS 0-2 or not worsening of the mRS score at three months. Secondary analyses included predicting a favorable outcome using multivariate logistic regression analysis.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: