Penumbra, Inc Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-06-26: Study NCT07749170; Company role Lead sponsor; Phase Observational; Status Recruiting.
- 2025-11-01: Study NCT07107022; Company role Lead sponsor; Phase Observational; Status Recruiting.
- 2025-10-29: Study NCT06168058; Company role Collaborator; Phase Not applicable; Status Recruiting.
- 2025-05-18: Study NCT06747117; Company role Lead sponsor; Phase Observational; Status Recruiting.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-06-26 | NCT07749170 FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions | Lead sponsor | Observational | Recruiting | Acute Ischemic Stroke; Acute Ischemic Stroke (AIS) Related to a Distal Occlusion | 250 | 2028-09 |
| 2025-11-01 | NCT07107022 Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS). | Lead sponsor | Observational | Recruiting | Acute Ischemic Stroke (AIS) | 200 | 2028-04 |
| 2025-10-29 | NCT06168058 Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices | Collaborator Lead: Weill Medical College of Cornell University | Not applicable | Recruiting | Chronic Pelvic Pain Syndrome; Pelvic Pain; Pelvic Varices; Pelvic Congestive Syndrome; Pelvic Pain Syndrome | 40 | 2027-06 |
| 2025-05-18 | NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) | Lead sponsor | Observational | Recruiting | Lower Extremity Acute Limb Ischemia; LE ALI | 300 | 2029-01 |
| 2023-12-07 | NCT06446024 Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan | Lead sponsor | Observational | Completed | Acute Limb Ischemia; Arterial Occlusion Mesenteric Artery Superior; Acute DVT of Lower Extremity | 500 | 2025-07-25 |
| 2023-11-27 | NCT05684796 Comparison of Two Pulmonary Embolism Treatments | Lead sponsor | Not applicable | Completed Results posted | Pulmonary Embolism Acute | 100 | 2025-09-09 |
| 2022-11-03 | NCT05460793 Dutch Intracerebral Hemorrhage Surgery Trial | Collaborator Lead: Radboud University Medical Center | Not applicable | Recruiting | Intracerebral Hemorrhage; Minimally Invasive Surgical Procedures; Endoscopic Surgical Procedures | 600 | 2028-07 |
| 2022-08-11 | NCT05437055 THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing | Lead sponsor | Not applicable | Completed | Acute Ischemic Stroke; Large Vessel Occlusion | 216 | 2024-12-10 |
| 2022-05-10 | NCT05128955 Embolization of the Splenic Artery After Trauma | Collaborator Lead: Andrew J. Gunn | Not applicable | Completed | High-grade Splenic Injuries | 180 | 2026-04-22 |
| 2021-12-09 | NCT05029414 EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusion sTroke | Collaborator Lead: University Hospital, Basel, Switzerland | Not applicable | Active not recruiting | Acute Ischemic Stroke | 543 | 2025-06-01 |
| 2021-09-30 | NCT05003843 BOLT-DVT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis | Lead sponsor | Not applicable | Active not recruiting | Deep Vein Thrombosis; DVT | 229 | 2028-01 |
| 2021-06-25 | NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System | Lead sponsor | Observational | Recruiting | Pulmonary Embolism | 1,500 | 2028-02 |
| 2021-02-16 | NCT04693767 Investigation of Clot in Ischemic Stroke and Hematoma Evacuation | Lead sponsor | Observational | Completed Results posted | Ischemic Stroke; Intracranial Hematoma | 400 | 2022-08-03 |
| 2020-09-23 | NCT04297787 Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment of Acute DVT | Collaborator Lead: University of Kansas Medical Center | Not applicable | Completed | Acute Deep Vein Thrombosis | 3 | 2023-06-16 |
| 2020-01-12 | NCT04157270 LOTUS: Global Acute Stroke Study Utilizing Penumbra System | Lead sponsor | Observational | Terminated | Stroke, Ischemic | 23 | 2021-05-10 |
| 2019-12-17 | NCT04144959 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System | Lead sponsor | Observational | Completed Results posted | Lower Extremity Acute Limb Ischemia; LE ALI | 119 | 2023-10-20 |
| 2019-11-05 | NCT04106583 Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities | Lead sponsor | Observational | Completed Results posted | Aneurysm, Brain | 572 | 2023-08-02 |
| 2019-09-26 | NCT04178746 PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase | Lead sponsor | Observational | Terminated | Intracerebral Hemorrhage; Brain Hemorrhage; Intraventricular Hemorrhage | 4 | 2021-06-02 |
| 2019-08-22 | NCT03957473 Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries | Lead sponsor | Observational | Completed Results posted | Coronary Vessel Occlusion | 400 | 2021-06-02 |
| 2018-12-03 | NCT03608423 Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study | Collaborator Lead: Radboud University Medical Center | Not applicable | Completed | Intracerebral Hemorrhage; Surgical Procedures, Minimally Invasive | 169 | 2022-04-07 |
| 2018-07-02 | NCT03464565 COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device | Lead sponsor | Observational | Completed | Stroke, Ischemic | 650 | 2020-01-17 |
| 2018-02-06 | NCT03342664 MIND: Artemis in the Removal of Intracerebral Hemorrhage | Lead sponsor | Not applicable | Completed Results posted | Cerebral Hemorrhage; Brain Hemorrhage; Cerebral Parenchymal Hemorrhage; Intracerebral Hemorrhage | 236 | 2024-09-23 |
| 2017-11-22 | NCT03218566 Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism | Lead sponsor | Not applicable | Completed Results posted | Pulmonary Embolism | 119 | 2019-04-05 |
| 2017-06 | NCT02079818 Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System | Lead sponsor | Phase 4 | Withdrawn | Visceral Artery Aneurysms; Arteriovenous Malformations | 0 | 2018-09 |
| 2017-02-08 | NCT02216643 EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke | Collaborator Lead: Hospital de Clinicas de Porto Alegre | Phase 3 | Completed | Stroke; Ischemic Stroke | 221 | 2019-06-30 |
| 2016-06-03 | NCT02729740 Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil | Lead sponsor | Not applicable | Completed Results posted | Intracranial Aneurysm | 995 | 2019-12-27 |
| 2016-02 | NCT02678169 European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke | Lead sponsor | Observational | Completed | Ischemic Stroke | 204 | 2017-11 |
| 2015-05 | NCT02122133 CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400 | Lead sponsor | Observational | Terminated | Intracranial Aneurysms | 67 | 2016-10-19 |
| 2014-03 | NCT02085551 Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery | Lead sponsor | Not applicable | Completed Results posted | Peripheral Arterial Occlusion or Emboli | 85 | 2015-09 |
| 2013-01 | NCT01754051 A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System | Lead sponsor | Observational | Completed | Intracranial Aneurysms | 100 | 2017-10-03 |
| 2012-12 | NCT01753388 Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms | Lead sponsor | Phase 2 | Withdrawn | Wide Neck Intracranial Aneurysms | 0 | 2017-06 |
| 2012-12 | NCT01092819 A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial | Lead sponsor | Observational | Completed | Stroke | 150 | 2013-12 |
| 2012-09 | NCT01636453 The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms | Lead sponsor | Not applicable | Completed Results posted | Wide-neck, Saccular Intracranial Aneurysms | 120 | 2016-12 |
| 2012-05 | NCT01429350 Assess the Penumbra System in the Treatment of Acute Stroke | Lead sponsor | Phase 4 | Completed Results posted | Ischemic Stroke | 108 | 2016-10 |
| 2012-04 | NCT01584609 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 | Lead sponsor | Not applicable | Completed Results posted | Acute Ischemic Stroke From Large Vessel Occlusion | 198 | 2017-12 |
| 2011-11 | NCT01465841 Study of the Penumbra Coil 400 System to Treat Aneurysm | Lead sponsor | Not applicable | Completed Results posted | Intracranial Aneurysms; Peripheral Aneurysms | 517 | 2017-06 |
| 2010-09 | NCT01193569 A Study of Survival and Outcome After Stroke | Lead sponsor | Observational | Completed | Ischemic Stroke | 142 | 2016-12-22 |
| 2009-09 | NCT00963989 Imaging Guided Patient Selection for Interventional Revascularization Therapy | Lead sponsor | Not applicable | Completed Results posted | Acute Ischemic Stroke | 146 | 2016-09 |
| 2008-10 | NCT00785161 Penumbra Imaging Collaborative Study (PICS) | Lead sponsor | Observational | Completed | Stroke | 289 | 2010-12 |
| 2006-06 | NCT00334061 Study to Assess the Safety and Effectiveness of the Penumbra System | Lead sponsor | Phase 2 | Completed Results posted | Stroke | 125 | 2007-11 |
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