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Active Clinical Trials:
Cleared by FDA (Registry):
Sponsor: Stryker Neurovascular
The ASSIST Registry is prospective, global, consecutive enrollment Registry which aims to determine the success of procedural and clinical outcomes associated with various mechanical thrombectomy techniques using Stryker Neurovascular devices in treatment of large vessel occlusions found in the anterior circulation. The neurovascular devices examined in this study are available commercially and indicated for use as mechanical access and mechanical thrombectomy tools.
COMPLETE Registry: International Acute Ischemic Stroke Registry with the Penumbra System Aspiration including the 3D Revascularization Device
Sponsor: Penumbra, Inc.
The COMPLETE Registry is a prospective, single-arm, multi-center observational registry that aims to collect real-world data on the performance and safety the 3D Revascularization Device as part of the Penumbra System in treatment of acute ischemic strokes by removing large vessel occlusions. The study includes sites across the globe.
EXCELLENT Registry: Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy
The EXCELLENT Registry is a prospective, single-arm, real-world, multi-center study with sites located globally which aims to assess the efficacy of the EmboTrap Revascularization Device. The EmboTrap is a commercially available device which functions as a stent-retriever in effort to trap, retain, and evacuate a variety of clots located in the vessels of the brain in event of acute ischemic stroke.
Still awaiting FDA clearance (Study/Trial):
The APPLY Study: A Prospective, Single-Center Study Appraising the Embolization of Aneurysms using the Balt Optima™ Coil System
Sponsor: Vascular Neurology of Southern California, Inc.
The APPLY Study is an investigator-initiated prospective, real-world, single-center, post-market study conducted in Thousand Oaks, California. The purpose of this study is to demonstrate the efficacy and safety of the Balt Optima™ Coil System in the treatment of intracranial aneurysms. The coil system assessed in this study is available in two profiles, helical and complex detachable coils, they vary in length, diameter, and softness.
SURF Study: A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms using WAVE Extra Soft Coils, as part of the Penumbra SMART COIL System
Sponsor: Penumbra, Inc.
The SURF Study is a prospective, multi-center, real-world, post-market study with sites across North America that aims to establish the safety and efficacy of the Penumbra SMART COIL System, this includes the WAVE Extra Soft Coils in the treatment of intracranial aneurysms. The system works as a fill and finish coil that is meant to adequately embolize various neurovascular lesions.
Sponsor: Investigator-Initiated Study funded by Genentech, Cerenovus, Medtronic, Penumbra, Stryker
The TESLA Trial is a prospective, randomized, open-label, blinded endpoint study that aims to determine the efficacy of intra-arterial mechanical thrombectomy in the treatment of acute ischemic stroke due to a large vessel occlusion in the anterior circulation. The trial is looking at moderate to large infarct volume as measured by an NCCT ASPECTS score of 2 to 5. The study randomizes enrolled patients into either of the two available standards of care treatments for ischemic stroke: best medical management using IV-rtPA or intra-arterial treatment with mechanical thrombectomy using FDA approved devices.
TIGER Study: Treatment with Intent to Generate Endovascular Reperfusion
Sponsor: Rapid Medical
The TIGER Study is a prospective, single-arm, multi-center, IDE study with sites located in the United States and parts of Europe. The study is looking to evaluate the safety and effectiveness of the Tigertriever device. The Tigertriever assists in restoring blood flow to vessels of the brain by removing large vessel occlusions in event of ischemic stroke.
Completed Clinical Trials:
- ATLAS Study
- ISST Trial
- NASA Registry
- POINT Trial
- TARGET Registry
- TRACK Registry
- TRANSFORM Registry
- TREVO Registry