Background Most conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.
Methods This is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.
Results Each study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.
Conclusions Tracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.
Data availability statement
No data are available.
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Contributors Substantial contributions to the conception or design of the work: RDL, DVB, JV, MM. Acquisition, analysis, or interpretation of data for the work: RDL, DVB, BSG, DC, JV, MM. Drafting the work or revising it critically for important intellectual content: All listed authors. Final approval of the version to be published: All listed authors. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: All listed authors.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests JV reports consulting agreements with Integra Life Sciences and Corindus Vascular Robotics. MM reports grants funding from the National Institutes of Health (NIH R21NS109575), consulting agreements with Medtronic and Cerenovus; stock options in Serenity Medical, Synchron, Endostream, and VICIS; and an affiliation with the JNIS editorial board. RDT reports consulting agreements with Siemens Healthineers, Johnson and Johnson, Q’Apel Medical, Rebound Therapeutics, Echovate, Viseon; stock holdings in Q’Apel Medical, Rebound Therapeutics, Echovate, Viseon, Synchron, Endostream Medical; and royalty fees from the Medical University of South Carolina. MIC reports consulting agreements with Terumo Microvention, Johnson and Johnson, Imperative Care, Medtronic Neurovascular; stock holdings in Q’Apel Medical, RIST Neurovascular, Echovate, Viseon, Synchron, Endostream Medical, and royalty fees from the Medical University of South Carolina. AST reports consulting agreements with Blockade Medical, Cardinal Consulting, Cerebrotech, Corindus Vascular Robotics, Medtronic Neurovascular, Endostream Medical, Terumo Microvention, Penumbra, Siemens Healthineers, Imperative Care, Three Rivers Medical, Vastrax, Shape Memory, Stryker Neurovascular, Serenity Medical, 880 Medical, Q’Apel Medical; stock holdings in Cerebrotech, Corindus Robotics, Endostream Medical, Imperative Care, Three Rivers Medical, Vastrax, Shape Memory, Synchron, Serenity Medical, BlinkTBI, Echovate, RIST, Apama, Pipe Therapeutics; is the Chief Medical Officer of Corindus Robotics; co-foundership of Imperative Care, Vastrax, National Education and Research (NEAR) Center, Neuro Technology Investors (NTI), Pipe Therapeutics; and board membership for BlinkTBI. JF reports equity in Imperative Care and an affiliation with the JNIS editorial board. RDL reports a consulting agreements with Imperative Care, Cerenovus, Siemens Healthineers; equity in Synchron, Endostream and Q’Apel Medical; and an affiliation with the JNIS editorial board. DVB, BSG, DC, RZ, and TS have no competing interest to report.
Provenance and peer review Not commissioned; externally peer reviewed.