Background: The EXCELLENT registry aimed to evaluate the effectiveness of the EMBOTRAP Revascularization Device in an all-comer population in a real-world setting, with a focus on the composition of retrieved clots.
Methods: EXCELLENT is a prospective, global registry of patients with acute ischemic stroke treated with EMBOTRAP as the first-line mechanical thrombectomy device conducted at 34 sites (25 sites contributing clot) from September 2018 to March 2021, utilizing core imaging and central histology laboratories blinded to clinical data, independent 90-day modified Rankin Scale assessment and Clinical Events Committee.
Results: After screening 3799 patients, a total of 997 subjects (mean age, 70.
Background: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval.
View Article and Find Full Text PDFBackground: We describe the first-in-human experience using the Balloon Occlusion Stroke Sheath (BOSS) balloon-guide catheter to perform stroke thrombectomy in 50 consecutive patients enrolled in the Flow Arrest Safety and Technical success with balloon-guide catheters trial. This aspiration system includes a novel 9.4F balloon-guide catheter conduit for the insertion and guidance of catheters with a balloon providing temporary flow arrest.
View Article and Find Full Text PDFIntrasaccular flow disruption is a viable alternative to other endovascular treatments for saccular or wide-necked bifurcation intracranial aneurysms; however, wide neck aneurysms with irregular shapes or shallow depth may not be amenable to treatment currently available intrasaccular devices. Here, we present the first ever case report of the novel Saccular Endovascular Aneurysm Lattice Embolization System (SEAL™). The versatile utility of the SEAL™ device is demonstrated in a patient with acute subarachnoid hemorrhage (SAH) from a ruptured, complex, left middle cerebral artery (MCA) trilobed shallow wide-necked bifurcation aneurysm.
View Article and Find Full Text PDFBackground: Efficacy of thrombectomy treatment in acute ischemic stroke large vessel occlusion (AIS-LVO) patients is time dependent. Direct admission to thrombectomy centers (vs. interhospital transfer) may reduce time to treatment and improve outcomes.
View Article and Find Full Text PDFBackground: The Penumbra SMART COIL System includes a novel generation of embolic coils composed of complex and WAVE shape properties with varying levels of softness.
Objective: To assess safety and efficacy of the SMART COIL System through a 1-year follow-up in patients with small intracranial aneurysms.
Methods: This subset analysis of the SMART Registry, a prospective, multicenter study, includes patients with small intracranial aneurysms (≤4 mm) treated with the SMART COIL System.
Introduction: Wide-necked middle cerebral artery bifurcation aneurysms pose specific challenges to endovascular management. Surgical clipping remains the standard treatment approach for these aneurysms in many centers. While recent data suggests the endovascular treatment may be comparable, a prospective datapoint has been lacking.
View Article and Find Full Text PDFBackground: There is conflicting evidence on the utility of intravenous (IV) alteplase in patients with emergent large vessel occlusion (ELVO) treated with mechanical thrombectomy (MT).
Methods: This was a post hoc analysis of the COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion. We compared clinical, procedural and angiographic outcomes of patients with and without prior IV alteplase administration.
Background And Purpose: The purpose of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry was to evaluate the generalizability of the safety and efficacy of the Penumbra System (Penumbra, Inc, Alameda) in a real-world setting.
Methods: COMPLETE was a global, prospective, postmarket, multicenter registry. Patients with large vessel occlusion-acute ischemic stroke who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device as frontline approach were enrolled at 42 centers (29 United States, 13 Europe) from July 2018 to October 2019.
Background: Cerebral vasospasm (CV) after aneurysmal subarachnoid hemorrhage (aSAH) is linked to worse neurological outcomes. The NeVa VS is a novel cerebral dilation device based on predicate stent retrievers. We report the results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following aSAH (VITAL) Study.
View Article and Find Full Text PDFPenumbra SMART COIL® (SMART) System is a novel generation embolic coil with varying stiffness. The study purpose was to report real-world usage of the SMART System in patients with intracranial aneurysms (ICA) and non-aneurysm vascular lesions. The SMART Registry is a post-market, prospective, multicenter registry requiring ≥75% Penumbra Coils, including SMART, PC400, and/or POD coils.
View Article and Find Full Text PDFBackground: The PerfusiOn imaging Selection of Ischemic sTroke patIents for endoVascular thErapy (POSITIVE) trial was designed to evaluate functional outcome in patients with emergent large vessel occlusion (ELVO) presenting within 0-12 hours with pre-specified bifurcated arms of early and late window presentation, who were selected for endovascular thrombectomy with non-vendor specific commercially available perfusion imaging software. Recent trials demonstrating the benefit of thrombectomy up to 16-24 hours following ELVO removed equipoise to randomize late window ELVO patients and therefore the trial was halted.
Methods: Up to 200 patients were to be enrolled in this FDA-cleared, prospective, randomized, multicenter international trial to compare thrombectomy and best medical management in patients with ELVO ineligible for or refractory to treatment with IV tissue plasminogen activator (IV-tPA) selected with perfusion imaging and presenting within 0-12 hours of last seen normal.
Background: Clot density (Hounsfield units, HU) and perviousness (post-contrast increase in the HU of clot) are thought to be associated with clot composition. We evaluate whether these imaging characteristics were associated with angiographic outcomes of aspiration and stent retriever thrombectomy in COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion.
Methods: Clot density and perviousness were measured by two independent operators who were blind to all the final angiographic and clinical outcomes.
Background: Thrombectomy is an efficacious treatment for acute ischemic stroke (AIS). However, relatively few studies to date have specifically examined the impact and clinical implications of age on outcomes for thrombectomy in anterior AIS.
Objective: To provide a snapshot of patient metrics and outcomes with respect to age following thrombectomy for anterior AIS to supplement the current body of data for predictors of clinical outcomes in a real-world setting.
Background: Thrombectomy for anterior large vessel occlusion less than 24 hours since last known well is now standard of care. Certain aspects of clinical trials may limit generalizability to 'real-world' practice.
Objective: To compare revascularization rates and outcomes for direct aspiration (ADAPT) and stent retriever thrombectomy following anterior acute ischemic stroke (AIS) in a real-life setting.
Background: Stent retriever thrombectomy of large-vessel occlusion results in better outcomes than medical therapy alone. Alternative thrombectomy strategies, particularly a direct aspiration as first pass technique, while promising, have not been rigorously assessed for clinical efficacy in randomised trials. We designed COMPASS to assess whether patients treated with aspiration as first pass have non-inferior functional outcomes to those treated with a stent retriever as first line.
View Article and Find Full Text PDFBackground: Tandem occlusive disease in the setting of acute ischemic stroke involving cervical and cerebral arteries has been associated with poor neurological outcome and poses significant challenges to neurointerventionists. Previously described endovascular methods typically involve carotid revascularization with stent placement prior to or following intracranial thrombectomy. Stent-based approaches, however, require the use of antiplatelet therapy which may increase the risk of hemorrhagic transformation.
View Article and Find Full Text PDFJ Neurointerv Surg
November 2013
Objective: AngioSuite was developed to allow the easy and accurate calculation of cerebral aneurysm volumes and packing densities. The present study was undertaken to validate its accuracy.
Methods: Mathematical models and software were created to facilitate more complex aneurysm volume calculations than previously described three-dimensional geometric models.