ASSIST Registry Studying Various Operator Techniques

Stryker

Status: Completed

Conditions: Ischemic Stroke

Treatments: Device: Mechanical Thrombectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT03845491

CDM10001414

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,492 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
2. Occlusion of intracranial anterior circulation vessel
3. Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 48 hours post-procedure
4. Subject is willing to comply with the protocol follow-up requirements
5. The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions For Use (IFU): Technique Category/Devices: SR Classic/SR + BGC, SR Combination/SR + Asp Cath ± Pump + BGC or LS, Direct Aspiration/Asp Cath ± Pump + BGC or LS,

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.

Trial design

1,492 participants in 3 patient groups

SR Classic

Description:

SR (Trevo®\]) + BGC (FlowGate2\] or Merci)

Treatment:

Device: Mechanical Thrombectomy

SR Combination

Description:

SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci)

Treatment:

Device: Mechanical Thrombectomy

Direct Aspiration

Description:

Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci)

Treatment:

Device: Mechanical Thrombectomy