Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-01 @ 4:37 PM
Study NCT ID:
NCT06946732
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 127}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-19', 'studyFirstSubmitDate': '2025-04-19', 'studyFirstSubmitQcDate': '2025-04-19', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of RV/LV', 'timeFrame': '48 hours', 'description': 'The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Surgical success rate', 'timeFrame': 'Immediately after surgery'}, {'measure': 'Changes in pulmonary artery pressure before and after surgery', 'timeFrame': '48 hours'}, {'measure': 'Changes in arterial oxygen pressure before and after surgery', 'timeFrame': '14 days'}, {'measure': 'Clinical deterioration incidence', 'timeFrame': '48 hours', 'description': 'Clinical deterioration incidence includes tracheal intubation, mechanical ventilation, arterial hypotension\\>1 hour or shock, cardiopulmonary resuscitation, significant deterioration of oxygenation, and emergency surgical thrombectomy)'}, {'measure': 'All-cause mortality rate', 'timeFrame': '1, 3, 6, 12 months'}, {'measure': 'Symptomatic PE recurrence rate', 'timeFrame': '1, 3, 6, 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Embolism (PE)']}, 'descriptionModule': {'briefSummary': 'The registry is to evaluate the safety and feasibility of catheter-directed aspiration for patients with high-risk and intermediate-high-risk pulmonary embolism using Acostream.', 'detailedDescription': 'The registry is a prospective, multicenter, observational study involving 130 patients across up to seven sites in China. The aim of this study is to evaluate the safety and feasibility of catheter-directed thrombectomy using Acostream in patients with high-risk and intermediate-high-risk pulmonary embolism. The primary endpoint of the study is the efficacy and safety of pulmonary thrombus removal, assessed by reduction of ventricular strain, decrease in vascular obstruction, overall clinical improvement, and the early mortality rate from pulmonary embolism. Secondary endpoints include the total mortality rate of PE and the incidence of complications in the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18≤Age≤85\n* Clinical symptoms and presentation consistent with pulmonary embolism (PE).\n* PE symptoms duration ≤ 14 days.\n* High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.\n* Intermediate-high risk PE patients with right ventricle dysfunction (right ventricle/ left ventricle \\>0.9) confirmed by computed tomography pulmonary angiography or transthoracic echocardiography.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Refusal to sign the informed consent form.\n* Presence of intracardiac thrombus.\n* Presence of chronic left heart failure with an ejection fraction lower than 30% Diagnosed thrombophilia.\n* History of severe or chronic pulmonary hypertension.\n* Serum creatinine level higher than 1.8 mg/dl.\n* Known serious and uncontrolled sensitivity to radiographic agents.'}, 'identificationModule': {'nctId': 'NCT06946732', 'briefTitle': 'Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)', 'orgStudyIdInfo': {'id': 'The ARTIST study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Acostream aspiration group', 'description': 'The pulmonary thrombus removal by Acostream.', 'interventionNames': ['Device: Acostream aspiration']}], 'interventions': [{'name': 'Acostream aspiration', 'type': 'DEVICE', 'description': 'The pulmonary thrombus removal by Acostream.', 'armGroupLabels': ['The Acostream aspiration group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200217', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'email': 'niqihong1989@163.com', 'phone': '15801900772'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qihong Ni', 'role': 'CONTACT', 'email': 'niqihong1989@163.com', 'phone': '15801900772'}, {'name': 'Meng Ye', 'role': 'CONTACT', 'email': '13817145123@163.com', 'phone': '13817145123'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xiamen Cardiovascular Hospital, Xiamen University', 'class': 'OTHER'}, {'name': 'Nantong University Affiliated Hospital', 'class': 'UNKNOWN'}, {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Shanghai No.1 Hospital', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Jinhua Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}