Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT05166733
Status:
UNKNOWN
Last Update Posted:
2021-12-22
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time between the onset of the disease and the opening of the blood vessels', 'timeFrame': 'Immediately after surgery', 'description': 'Calculate the time from onset to vessel opening'}, {'measure': 'Functional independence at 90 days (defined as mRS≤2)', 'timeFrame': '90day after surgery', 'description': 'mRS scores were performed 90 days after surgery'}, {'measure': 'Symptomatic intracranial hemorrhage within 24 hours after surgery', 'timeFrame': '24 hours after surgery', 'description': 'Symptomatic intracranial hemorrhage was evaluated by CT 24 hours after operation'}], 'secondaryOutcomes': [{'measure': 'Time from onset to admission', 'timeFrame': 'Immediately after surgery', 'description': 'Calculate the time from onset to admission'}, {'measure': 'Time from admission and puncture time', 'timeFrame': 'Immediately after surgery', 'description': 'Calculate the time from onset to admission'}, {'measure': 'Puncture to the time of vessel opening', 'timeFrame': 'Immediately after surgery', 'description': 'Calculate the time from puncture to vascular opening'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ischemic stroke', 'Reco', 'endovascular treatment'], 'conditions': ['Neurology', 'Interventional Therapy']}, 'descriptionModule': {'briefSummary': 'To explore the differences in the green channel process of stroke in various regions of the same province, to target and shorten the time delay of emergency process, and to explore the key technologies of endovascular treatment of acute ischemic stroke. To investigate the use and embolectomy effect of Reco, the first embolectomy stent in China, in economically developed areas. Health economic assessment (cost-benefit analysis) of ischemic stroke patients in various regions of the province.', 'detailedDescription': 'The Reco Embolectomy Stent is indicated for patients who cannot be treated with intravenous tissue activator (IVt-PA) or who have failed IVt-PA therapy and is intended to remove thrombus from a large intracranial vessel in patients with ischemic stroke to restore blood flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing endovascular treatment for acute ischemic stroke with the Reco Embolectomy Stent from December 2018 to June 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age ≥18 years\n* The clinical diagnosis was acute ischemic stroke\n* Large vascular lesions were detected by head CT, CTA, MRI, MRA or DSA\n* Preoperative baseline NIHSS score \\> 4\n* MRS 0-1 before this stroke\n* Mechanical thrombectomy was performed\n* Use Reco thrombectomy bracket\n\nExclusion Criteria:\n\n* epileptic seizure\n* Sudden coma\n* Neurological loss symptoms quickly improved\n* Imaging was negative, but clinical symptoms did not rule out subarachnoid hemorrhage\n* Previous intracranial hemorrhage, subarachnoid hemorrhage, and brain tumor (with mass effect)\n* History of head trauma within 3 months prior to surgery\n* History of arterial puncture with difficulty in compression and hemostasis within one week prior to surgery\n* Physical examination revealed evidence of active bleeding or trauma (e.g. fracture)\n* Women are known to be pregnant or breastfeeding\n* Severe allergies to contrast agents are known'}, 'identificationModule': {'nctId': 'NCT05166733', 'briefTitle': 'A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': "The First People's Hospital of Changzhou"}, 'officialTitle': 'A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': '2021（ke）CL274'}}, 'contactsLocationsModule': {'locations': [{'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Jie Cao', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}], 'centralContacts': [{'name': 'Jie Cao', 'role': 'CONTACT', 'email': 'mayday509@163.com', 'phone': '13646125766'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PengYa', 'class': 'OTHER'}, 'collaborators': [{'name': "Jingjiang People's Hospital", 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, {'name': "Northern Jiangsu People's Hospital", 'class': 'OTHER'}, {'name': "Yixing People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'PengYa', 'investigatorAffiliation': "The First People's Hospital of Changzhou"}}}}