[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Penumbra Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100573502","a-study-of-patients-with-lower-extremity-acute-limb-ischemia-to-remove-thrombus-with-the-indigo-aspiration-system-stride-ii-100573502",false,"NCT06747117","A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)","STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II","STRIDE II","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac\n* Acute occlusion with symptom duration of 14 days or less at presentation\n* ALI Rutherford Category I, IIa or IIb\n* First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing\n* Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board\u002FEthics Committee requirements\n* Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year\n* Target vessel size \\\u003C2 mm\n* Target thrombus is in the aorta or isolated profunda artery\n* Prior major amputation (proximal to the tarsometatarsal joint) in the target limb\n* Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight\n* LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies\n* Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed \\\u003C 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery\n* Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment\n* Pregnancy\n* Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated\n* Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study\n* Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).",[25,26],"Lower Extremity Acute Limb Ischemia","LE ALI","RECRUITING","2026-06-17",{"date":30,"type":31},"2026-06-18","ACTUAL",{"date":33,"type":31},"2025-05-18",{"date":35,"type":21},"2029-01",{"name":37,"class":38},"Penumbra Inc.","INDUSTRY",38,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100601171","study-to-collect-real-world-performance-and-safety-data-on-penumbra-system-in-population-with-acute-ischemic-stroke-ais-100601171","NCT07107022","Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).","i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®","i-RISE","Inclusion Criteria:\n\n* I.1. Patient age 18-75 years\n* I.2. Pre-stroke mRS 0-1\n* I.3. Patients experiencing acute ischemic stroke who are eligible for mechanical thrombectomy using the Penumbra System\n* I.4. Frontline treatment with Penumbra System\n* I.5. Signed informed consent per Institution Review Board\u002FEthics Committee\n\nExclusion Criteria:\n\n* E.1. Alberta Stroke Program Early CT Score (ASPECTS) ≤6 (for anterior circulation strokes)\n* E.2. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days\n* E.3. Currently participating in an investigational (drug, device, etc.) clinical trial that will influence the endovascular procedure or acute treatment of the patient. Patients in secondary prevention, observational, natural history, and\u002For\n* epidemiological studies are eligible.\n* E.4. Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study","75 Years",{"count":50,"type":21},200,"The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)",[53],"Acute Ischemic Stroke (AIS)",[55,56,57,58,59,60],"Penumbra System","Thrombectomy","Penumbra ENGINE®","mechanical thrombectomy","Neuro Thrombectomy","Neurovascular Catheters","2026-06-05",{"date":63,"type":31},"2026-06-08",{"date":65,"type":31},"2025-11-01",{"date":67,"type":21},"2028-04",{"name":37,"class":38},10,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100423775","study-of-the-long-term-safety-and-outcomes-of-treating-pulmonary-embolism-with-the-indigo-aspiration-system-100423775","NCT04798261","Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System","STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism","Inclusion Criteria:\n\n1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less\n2. RV\u002FLV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram\n3. Frontline endovascular treatment with the Indigo Aspiration System per IFU\n4. Patient is ≥ 18 years of age\n5. Informed consent obtained per Institutional Review Board\u002FEthics Committee requirements\n\nExclusion Criteria:\n\n1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)\n2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation\n3. Known serious, uncontrolled sensitivity to radiographic agents\n4. Life expectancy \\\u003C 180 days\n5. Patients on ECMO\n6. Pregnant patients\n7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies\n8. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study",{"count":78,"type":21},1500,"The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).",[81],"Pulmonary Embolism","2026-05-14",{"date":84,"type":31},"2026-05-18",{"date":86,"type":31},"2021-06-25",{"date":88,"type":21},"2028-02",{"name":37,"class":38},76,""]