Stroke Trials

1.  ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

Prospective, multicenter, randomized study comparing the safety and efficacy of the ReStore Thrombectomy Device with the MERCI Retrieval System in acute ischemic stroke patients who require mechanical thrombectomy. Study sponsor is Reverse Medical Corporation. Recruitment is currently suspended.

2.  Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke (THRACE)

Randomized, controlled, multicenter trial comparing outcomes and cost effectiveness of a combined approach of IV thrombolysis plus mechanical thrombectomy to the reference treatment of IV thrombolysis alone in patients who present with acute ischemic stroke within four hours of symptom onset. Study sponsor is Central Hospital, Nancy, France. Currently recruiting participants.

3.  Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE)

Randomized, controlled trial of adjunctive mechanical thrombectomy (in addition to IV thrombolysis) compared with IV thrombolysis alone in patients with acute ischemic stroke. Study sponsor is NHS Greater Glasgow and Clyde. Study is not yet open for recruitment.

4.  Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE)

Randomized, controlled trial evaluating whether rapid endovascular revascularization amongst radiologically selected (small core/proximal occlusion) patients with ischemic stroke within 12 hours of last seen normal results in improved outcomes compared to patients treated with best standard of medical care, including IV thrombolysis to those eligible. Study sponsor is University of Calgary. Enrolling participants by invitation only.

5.  Solitaire FR Thrombectomy for Acute Revascularisation (STAR)

Observational clinical evaluation of the safety and efficacy of the Solitaire FR Device in acute ischemic stroke patients requiring mechanical thrombectomy when used according to its Instructions For Use. Study sponsor is ev3. Study is ongoing but not recruiting patients.

6.  Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry (PRIISM2)

Prospective, observational, cohort study to determine the revascularization rate, clinical efficacy, and safety of the CE-marked MindFrame System in ischemic stroke patients. Study sponsor is MindFrame, Inc. The study is ongoing, but not recruiting participants.

7.  POSITIVE Stroke Clinical Trial

Randomized trial to determine the safety and efficacy of intra-arterial reperfusion in acute ischemic stroke patients ineligible for IV-TPA as selected by physiologic imaging. Study sponsor is Medical University of South Carolina. This study is not yet open for participant recruitment.

8.  Assess the Penumbra System in the Treatment of Acute Stroke (THERAPY)

Randomized, controlled trial to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to IV-TPA in patients with acute ischemic stroke from large vessel occlusion in the brain. Patients must be eligible to receive IV-TPA and have evidence of a large clot burden (clot length > 8 mm). Study sponsor is Penumbra, Inc. This study is currently recruiting participants.

9.  Penumbra Imaging Collaborative Study (PICS)

Observational cohort study whose primary aim is to gather data on the “real world” experience of the Penumbra System and to determine if there is a correlation between the imaging-defined size of the ischemic penumbra at admission and the outcomes in patients already treated by the System. Study sponsor is Penumbra, Inc. This study is ongoing, but not recruiting participants.

10.  Solitaire™ FR as Primary Treatment for Acute Ischemic Stroke (SWIFT PRIME)

Randomized, controlled trial to determine if patients with acute ischemic stroke due to a large vessel occlusion treated with combined IV-TPA and Solitaire FR within 6 hours of symptom onset have less stroke-related disability than those patients treated with IV TPA alone. Study sponsor is Covidien. This study is currently recruiting participants.

11.  ADAPT: A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke

Retrospective, observational, multicenter study comparing a direct aspiration, first pass technique to traditional thrombectomy devices in patients undergoing thrombectomy for acute stroke. Study sponsor is Medical University of South Carolina. This study is not yet open for participant recruitment.

12.  A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

Prospective, randomized, controlled, multicenter trial evaluating the safety and effectiveness of the Penumbra Separator 3D as a component of the Penumbra System for the revascularization of large vessel occlusion in acute ischemic stroke. Patients will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System alone without the Separator 3D. Study sponsor is Penumbra, Inc. This study is currently recruiting participants.

13.  Feasibility Study of IV rtPA vs. Primary Endovascular Therapy for Acute Ischemic Stroke (EARLY)

Randomized pilot trial comparing endovascular reperfusion therapy to IV-TPA in patients able to receive the assigned treatment within 4.5 hours of symptom onset. Study sponsor is Mayo Clinic. This study is currently recruiting participants.

14.  Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial (EXTEND-IA)

Randomized, controlled trial comparing intra-arterial reperfusion therapy with the Solitaire device after standard dose IV-TPA to IV-TPA alone in patients with acute ischemic stroke. Patients must be eligible to receive IV-TPA within 4.5 hours of symptom onset, and demonstrate a large vessel occlusion and mismatch on imaging. Study sponsor is National Stroke Research Institute, Australia. This study is currently recruiting participants.

15.  Intra-arterial Magnesium Administration for Acute Stroke

Non-randomized study to evaluate the safety and feasibility of directed, intra-arterial magnesium measurement and therapy, through endovascular access, in acute stroke patients. Study sponsor is University of Southern California. This study is currently recruiting participants.

16.  Swiss Intravenous and Intra-arterial Thrombolysis for Treatment of Acute Ischemic Stroke Registry (SWISS)

Observational cohort study of patients with acute ischemic stroke treated with IV or IA thrombolysis in a Swiss stroke unit. Clinical and radiographical data will be evaluated. Study sponsor is University Hospital Inselspital, Berne. This study is currently recruiting participants.

17.  Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention (WASSABI)

Randomized trial studying the safety and effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset. Patients will be assigned to standard medical therapy, IV thrombolysis, or intra-arterial intervention. Study sponsor is Jacobs Neurological Institute. This study is currently recruiting participants.

18.  Study of ALD-401 Via Intracarotid Infusion in Ischemic Stroke Subjects

Randomized, sham-controlled, multicenter trial designed to determine the safety and efficacy of ALD-401 delivered by intracarotid infusion in treating patients with primary ischemic stroke. ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the stroke. Study sponsor is Aldagen. This study is currently recruiting participants.

19.  Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome (ANSTROKE)

Prospective, randomized study to evaluate whether general anesthesia or sedation technique is preferable during embolectomy for acute stroke, measured in terms of three month neurological impairment and complication frequency between the methods. Study sponsor is Sahlgrenska University Hospital, Sweden. This study is currently recruiting participants.

20.  Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT)

Prospective, multicenter, randomized, controlled trial to evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is superior to medical management alone (including IV-TPA) in achieving favorable outcomes in the distribution of mRS scores at 90 days in patients presenting with acute large vessel ischemic stroke < 8 hours from symptom onset. Study sponsor is Fundacio Ictus Malaltia Vascular. This study is currently recruiting participants.

21.  Basilar Artery International Cooperation Study (BASICS)

Randomized, controlled, multicenter trial evaluating the efficacy and safety of additional intra-arterial treatment after IV thrombolysis in patients with basilar artery occlusion confirmed by CTA or MRA. Eligible patients must receive IV thrombolysis within 4.5 hours from symptom onset. Patients will be randomized between additional intra-arterial treatment after IV thrombolysis or IV thrombolysis alone. Study sponsor is Erik van der Hoeven, St. Antonius Hospital. This study is currently recruiting participants.

22.  A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Open label, nonrandomized, multicenter safety study of Plasmin (Human) in patients with stroke due to a clot in the middle cerebral artery. Plasmin will be administered through a catheter into the thrombus within 9 hours of stroke onset. Three doses of Plasmin will be tested in 3 different groups of patients. Study sponsor is Grifols Therapeutics Inc. This study is currently recruiting participants.

23.  Autologous Bone Marrow Stem Cells in Ischemic Stroke

Nonrandomized safety and tolerability study of an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome. Study sponsor is Imperial College London. This study is currently recruiting participants.

24.  Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE)

Randomized, controlled trial of the efficacy, tolerability, practicability, and safety of endovascular cooling versus surface cooling in awake stroke patients. Study sponsor is University Hospital Heidelberg. This study is currently recruiting participants.

25.  International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE)

Observational cohort study to gather information on predictors of good or poor clinical outcome following mechanical recanalization therapies for acute ischemic stroke. Study sponsor is Goethe University. This study is currently recruiting participants.

26.  Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project (CRISP)

In the first part of this study, the investigators propose to develop a fully automated CTP analysis program. Part two is a prospective cohort study to demonstrate that this CTP analysis program can help accurately identify acute stroke patients who are likely to benefit from endovascular therapy. Study sponsor is Stanford University. This study is currently recruiting participants.

27.  Imaging Guided Patient Selection for Interventional Revascularization Therapy (START)

Non-randomized, single group study to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom onset and with a known core infarct volume on admission. The study will also determine if there is a correlation between infarct volume and functional outcome in treated patients at 90 days post-procedure. Study sponsor is Penumbra, Inc. This study is ongoing, but not recruiting participants.

28.  Endovascular Acute Stroke Intervention Trial - the EASI Trial

Randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment. Study sponsor is CHUM Notre-Dame hospital, Montreal, Canada. Currently recruiting participants.