ASSIST Registry Studying Various Operator Techniques
Purpose
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).
Condition
- Ischemic Stroke
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| SR Classic | SR (Trevo®]) + BGC (FlowGate2] or Merci) |
|
| SR Combination | 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) |
|
| Direct Aspiration | 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) |
|
More Details
- Status
- Completed
- Sponsor
- Stryker Neurovascular
Study Contact
Detailed 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.