Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-31 @ 9:33 PM
Study NCT ID:
NCT05577351
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017131', 'term': 'Thrombectomy'}], 'ancestors': [{'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, multi-center, open-label, single-arm study to assess the initial technical effectiveness and safety of the RapidPulseTM (feasibility version). As such, no formal statistical hypothesis will be tested in this study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-09', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frontline Technical Success', 'timeFrame': 'Intra-procedural', 'description': 'As defined by mTICI 2b or greater after the last pass with Study Device (no rescue therapy)'}, {'measure': 'Final mTICI', 'timeFrame': 'Intra-procedural', 'description': 'After all passes (including any rescue therapy)'}, {'measure': 'Modified First Pass Reperfusion Effect (mFPE)', 'timeFrame': 'Intra-procedural', 'description': 'Defined as mTICI 2b or greater after one device pass'}, {'measure': 'Device-related and procedure-related adverse events', 'timeFrame': 'Intra and post-procedural (up to 24 hours)', 'description': 'Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm'}], 'primaryOutcomes': [{'measure': 'First Pass Reperfusion Effect (FPE)', 'timeFrame': 'Intra-procedural', 'description': 'Defined by mTICI greater than or equal to 2c after one reperfusion attempt'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Large Vessel Occlusion', 'Mechanical Thrombectomy', 'Neurovascular Intervention'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'A feasibility study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO) in the intracranial ICA, M1, M2, basilar or vertebral arteries.', 'detailedDescription': 'The purpose of this prospective, open label clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The study will enroll up to a maximum of 50 subjects in 2 centers in Georgia. Subjects will undergo mechanical thrombectomy procedure and will have post-operative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours\n* Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery\n* Target occlusion can be accessed by the Medtronic React 71 aspiration catheter\n\nExclusion Criteria:\n\n* Known or suspected intracranial atherosclerotic disease (ICAD)\n* Tandem occlusions'}, 'identificationModule': {'nctId': 'NCT05577351', 'acronym': 'PULSE-F', 'briefTitle': 'Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'RapidPulse, Inc'}, 'officialTitle': 'PULSE-F: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions', 'orgStudyIdInfo': {'id': 'CIP-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove thrombus in the neuro-vasculature using the RapidPulseTM (feasibility) device.', 'interventionNames': ['Device: RapidPulseTM Aspiration System']}], 'interventions': [{'name': 'RapidPulseTM Aspiration System', 'type': 'DEVICE', 'otherNames': ['Aspiration Thrombectomy'], 'description': 'The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'National Institute of Surgery', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Pineo Medical Ecosystems', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}], 'overallOfficials': [{'name': 'Raul G Nogueira, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh Medical Center Stroke Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RapidPulse, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}