ASSIST Registry Studying Various Operator Techniques

  • STATUS
    Recruiting
  • End date
    Dec 10, 2021
  • participants needed
    1500
  • sponsor
    Stryker Neurovascular
Updated on 10 June 2021
stroke
thrombectomy

Summary

The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).

Description

ASSIST is a prospective, global, consecutive enrollment Registry of anterior circulation acute ischemic stroke patients with an LVO who undergo treatment with one of the interventional techniques using Stryker Neurovascular devices for the first pass. The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO) in the anterior circulation. Data will be collected on the use of Stryker market-released neurovascular mechanical access and mechanical thrombectomy devices that are commercially available or that may be approved for commercial use during the conduct of the Registry. This Registry will also collect data, including time-to-treatment and quality of life measures, to allow for subset analyses.

Details
Condition Ischemic Stroke
Treatment Mechanical Thrombectomy
Clinical Study IdentifierNCT03845491
SponsorStryker Neurovascular
Last Modified on10 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects experiencing acute ischemic stroke (AIS) who are eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
Occlusion of intracranial anterior circulation vessel
Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 48 hours post-procedure
Subject is willing to comply with the protocol follow-up requirements
Subject is treated using at least one of the defined techniques for the first pass in the neurovasculature to remove thrombus

Exclusion Criteria

The subject is participating in another device trial or any other clinical trial where the study procedure or treatment might confound this study's endpoint
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