N/A N=1,492

ASSIST Registry Studying Various Operator Techniques

Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT03845491 ↗

Enrolled (actual)

1,492

Serious AEs

31.2%

Results posted

May 2025

Primary outcome: Primary: Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90 — 140; 351; 273 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Mechanical Thrombectomy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stryker Neurovascular
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90	140; 351; 273	—
PRIMARY Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)	110; 309; 193	—
SECONDARY Percentage of Subjects With an Excellent Functional Outcome at Day 90	112; 264; 209	—
SECONDARY Percentage of Subjects With an "Early Response" Defined by NIHSS Score	156; 376; 294	—
SECONDARY Quality of Life at Day 90 Based on EQ5D5L Score	103; 247; 187; 36; 94; 77	—
SECONDARY Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.	66; 179; 200; 16; 55; 52	—
SECONDARY Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass	21.94; 23.31; 20.14; 25.68; 28.85; 19.24	—
SECONDARY Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3	29.17; 31.26; 27.05	—

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).

Eligibility Criteria

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
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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03845491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.