Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT07137832
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 530}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety outcome: Symptomatic intracranial hemorrhage (sICH)', 'timeFrame': '24 (±12) hours', 'description': 'Symptomatic intracranial hemorrhage (sICH) within 36 hours (according to Heidelberg criteria)'}, {'measure': 'Safety outcome: Any intracranial hemorrhage', 'timeFrame': '24 (±12) hours', 'description': 'Any intracranial hemorrhage within 36 hours (according to Heidelberg classification);'}, {'measure': 'Safety outcome: Mortality', 'timeFrame': '90 (±14) days', 'description': 'All-cause mortality within 90 days.'}], 'primaryOutcomes': [{'measure': 'The modified Rankin Scale score (mRS) 0-1', 'timeFrame': '90 (±14) days', 'description': 'The proportion of mRS 0-1 at 90 (±14) days.'}], 'secondaryOutcomes': [{'measure': 'Level of disability', 'timeFrame': '90 (±14) days', 'description': 'The shift analysis of mRS at 90 (±14) days (mRS 5 and 6 merged)'}, {'measure': 'The modified Rankin Scale score (mRS) 0-2', 'timeFrame': '90 (±14) days', 'description': 'The proportion of mRS 0-2 at 90 (±14) days;'}, {'measure': 'Quality of life (EQ-5D-5L)', 'timeFrame': '90 (±14) days', 'description': 'Quality of life measured by the EQ-5D-5L scale score at 90 (±14) days'}, {'measure': 'Neurologic deficit (NIHSS score) changes', 'timeFrame': '24 (±12) hours', 'description': 'The change of NIHSS score from baseline at 24 (±12) hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of intra-arterial thrombolysis as adjunct to endovascular treatment in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.', 'detailedDescription': 'PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of intra-arterial thrombolysis as adjunct to endovascular treatment in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset. The primary outcome is the proportion of patients with a 90-day modified Rankin Scale (mRS) of 0-1. Eligible patients will be randomly assigned at a ratio of 1:1 into the intervention group to receive intra-arterial thrombolysis as adjunct to endovascular treatment, or the control group to receive only standard medical management. A total of 530 participants (265 per group) are anticipated to be recruited for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Clinical diagnosis of acute ischemic stroke.\n3. CT angiography (CTA) or MR angiography (MRA) confirmed primary isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA, or the P1/P2/P3 segment of the PCA).\n4. Baseline NIHSS ≥6.\n5. Treatment (arterial puncture) can be initiated 5.1 Within 6 hours of last known well (LKW) OR 5.2 Within 6 to 24 hours of LKW AND evidence of salvageable brain tissue on CT perfusion or perfusion-diffusion MRI (ischemic core volume \\<50mL, hypo-perfused tissue volume to ischemic core volume ratio \\>1.4, mismatch volume \\>10mL). Hypo-perfused tissue is defined as Tmax \\>6s on CT perfusion or perfusion MRI. Ischemic core is defined as rCBF \\<30% on CT perfusion or ADC \\<620μm2/s on diffusion MRI.\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Evidence of intracranial hemorrhage.\n2. Pre-stroke mRS score ≥ 2.\n3. Rapidly improving symptoms, in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of \\<6 at randomization.\n4. The intervention procedure is unlikely to be completed as assessed by the investigator.\n5. Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis.\n6. Suspected arterial dissection.\n7. Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast.\n8. Known genetic or acquired bleeding disposition or anticoagulant factors deficiency.\n9. Coagulation disorder with INR \\>1.7 or use of new oral anticoagulants within 48 hours prior to symptom onset.\n10. Platelet count \\<50×10\\^9/L.\n11. Any active or recent bleeding (gastrointestinal, urinary tract bleeding, etc.), or previous parenchymal organ surgery or biopsy in the last 1 month.\n12. Systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg, refractory to treatment.\n13. Known severe renal insufficiency with glomerular filtration rate \\<30 ml/min or blood creatinine \\>220 μmol/L (2.5 mg/dl).\n14. Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma).\n15. Anticipated life expectancy \\<6 months due to advanced disease (e.g., malignancy, severe cardiopulmonary disease, etc.).\n16. Women who are pregnant or breastfeeding.\n17. Participation in other clinical trials.\n18. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).'}, 'identificationModule': {'nctId': 'NCT07137832', 'acronym': 'PEARL-MeVO', 'briefTitle': 'OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion (PEARL-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial', 'orgStudyIdInfo': {'id': 'SYSKY-2025-574-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intra-arterial thrombolysis as adjunct to endovascular treatment, in addition to standard medical treatment', 'interventionNames': ['Combination Product: Intra-arterial thrombolysis as adjunct to endovascular treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Only standard medical treatment', 'interventionNames': ['Other: Standard medical treatment']}], 'interventions': [{'name': 'Intra-arterial thrombolysis as adjunct to endovascular treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'Intra-arterial thrombolysis as adjunct to endovascular treatment, in addition to standard medical treatment', 'armGroupLabels': ['Intervention group']}, {'name': 'Standard medical treatment', 'type': 'OTHER', 'description': 'Standard medical treatment', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenhong Deng', 'role': 'CONTACT', 'email': 'dengzhh58@mail.sysu.edu.cn', 'phone': '86-20-81332619'}, {'name': 'Xinguang Yang', 'role': 'CONTACT', 'email': 'yangxinguang0926@163.com', 'phone': '86-20-81332619'}, {'name': 'Yamei Tang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhenhong Deng', 'role': 'CONTACT', 'email': 'dengzhh58@mail.sysu.edu.cn', 'phone': '86-20-81332619'}, {'name': 'Xinguang Yang', 'role': 'CONTACT', 'email': 'yangxinguang0926@163.com', 'phone': '86-20-81332619'}], 'overallOfficials': [{'name': 'Yamei Tang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months after the trial completion.', 'ipdSharing': 'YES', 'description': 'The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.', 'accessCriteria': 'The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}