Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT05086016
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-25
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Growth Trial: Study of the Renata Minima Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001017', 'term': 'Aortic Coarctation'}, {'id': 'D000071079', 'term': 'Stenosis, Pulmonary Artery'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dali@renatamedical.com', 'phone': '8553184988', 'title': 'Dali Alarian', 'phoneExt': '6', 'organization': 'Renata Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events are collected through study completion. Structured visits include at time of procedure, post-procedure/discharge, 1 month, 3 months, 6 months 12 months, and annually thereafter through 5 years.', 'description': 'Serious Adverse Events are defined as procedure- or device-related SAEs resulting in an event of Death, Cardiac arrest and/or emergency ECMO cannulation, Stroke, Limb loss, Vessel dissection of target lesion, Device thrombosis/occlusion, Cardiac perforation requiring percutaneous or open surgical intervention, Persistent cardiac arrhythmia requiring a pacemaker.\n\nAdverse Events are defined as events related or possibly related to procedure or device', 'eventGroups': [{'id': 'EG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 5, 'seriousNumAtRisk': 42, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Access Site Complications', 'notes': 'Pulse Loss, Thrombus, Rebleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Demonstrating Clinical Success at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 6-month follow-up Visit', 'description': 'The primary efficacy endpoint will be assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%.\n\nClinical success is defined as:\n\n* Stenosis relief, defined by stent outer diameter ≥ 75% of the surrounding vessel immediately after deployment.\n* Freedom from open surgical intervention required to treat Minima Stent disfunction through 6 months.\n* Maintenance of stented vessel diameter ≥ 50% of post-implant diameter at 6 months; as measured using CT angiography and/or angiography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Freedom From Serious Adverse Events at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 6-month follow-up Visit', 'description': 'The primary safety endpoint will be assessed as the percentage of cases with freedom from procedure- or device-related SAEs resulting in an event listed below, with the performance goal defined as greater than 78% of cases:\n\n* Death\n* Cardiac arrest and/or emergency ECMO cannulation\n* Stroke\n* Limb loss\n* Vessel dissection of target lesion\n* Device thrombosis/occlusion\n* Cardiac perforation requiring percutaneous or open surgical intervention\n* Persistent cardiac arrhythmia requiring a pacemaker', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'immediately after deployment', 'description': 'When a pressure gradient provides a reliable hemodynamic variable (e.g., coarctation of the aorta), a reduction in ventricle to arterial or arterial to arterial peak-to-peak pressure gradient to \\< 20 mmHg after stent placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a Minima Stent deployed in the aortic circulation'}, {'type': 'SECONDARY', 'title': 'Successful Stent Re-dilation at Re-catheterization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Stent Re-Dilation Procedures', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Immediately after re-dilation', 'description': 'Successful stent re-dilation (when indicated) at re-catheterization, defined as an increase in the intra stent angiographic luminal diameter within 2mm of the adjacent native vessel diameter immediately after re-dilation.', 'unitOfMeasure': 'Stent Re-Dilation Procedures', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stent Re-Dilation Procedures', 'denomUnitsSelected': 'Stent Re-Dilation Procedures', 'populationDescription': '15 patients have had at least one re-dilation with a total of 15 initial re-dilations and 6 second re-dilations (21 total re-dilations).'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Freedom From Stent Embolization or Migration at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'Stent Implants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 months', 'description': 'Freedom from stent embolization or migration through 6 months.', 'unitOfMeasure': 'Stent Implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stent Implants', 'denomUnitsSelected': 'Stent Implants'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Freedom From Stent Fracture at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Freedom from stent fracture that led to reintervention through 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Stent Re-Dilation Procedures', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '90 days post re-dilation', 'description': 'Freedom from non-elective Minima Stent explant at 90-days post re-dilation procedure', 'unitOfMeasure': 'Stent Re-Dilation Procedures', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stent Re-Dilation Procedures', 'denomUnitsSelected': 'Stent Re-Dilation Procedures', 'populationDescription': '20 re-dilation procedures (14 post-initial re-dilation and 6 post-second re-dilation) across 14 subjects that have reached the 90 days post re-dilation procedure endpoint for assessment'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Stent Re-Dilation Procedures', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).\n\nCatheterized Stenting: Catheterized stenting of vascular narrowings.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Immediately after re-dilation', 'description': 'Freedom from procedure- or device-related SAE during re-dilation that results in the following:\n\n* Death\n* Cardiac arrest and/or emergency ECMO cannulation\n* Stroke\n* Limb loss\n* Vessel dissection of target lesion\n* Device thrombosis/occlusion\n* Cardiac perforation requiring percutaneous or open surgical intervention\n* Persistent cardiac arrhythmia requiring a pacemaker', 'unitOfMeasure': 'Stent Re-Dilation Procedures', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stent Re-Dilation Procedures', 'denomUnitsSelected': 'Stent Re-Dilation Procedures'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '45', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Of the 42 enrolled patients, 39 patients were treated with 1 Minima Stent and 3 patients with 2 Minima Stents, for a total of 45 Minima Stent Implants.', 'groupId': 'FG000', 'numUnits': '45', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Stent Implants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '112'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-07', 'size': 348113, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-18T14:40', 'hasProtocol': True}, {'date': '2024-01-24', 'size': 324944, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-18T14:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2021-10-07', 'resultsFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-12', 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Demonstrating Clinical Success at 6 Months', 'timeFrame': 'Through 6-month follow-up Visit', 'description': 'The primary efficacy endpoint will be assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%.\n\nClinical success is defined as:\n\n* Stenosis relief, defined by stent outer diameter ≥ 75% of the surrounding vessel immediately after deployment.\n* Freedom from open surgical intervention required to treat Minima Stent disfunction through 6 months.\n* Maintenance of stented vessel diameter ≥ 50% of post-implant diameter at 6 months; as measured using CT angiography and/or angiography.'}, {'measure': 'Number of Participants With Freedom From Serious Adverse Events at 6 Months', 'timeFrame': 'Through 6-month follow-up Visit', 'description': 'The primary safety endpoint will be assessed as the percentage of cases with freedom from procedure- or device-related SAEs resulting in an event listed below, with the performance goal defined as greater than 78% of cases:\n\n* Death\n* Cardiac arrest and/or emergency ECMO cannulation\n* Stroke\n* Limb loss\n* Vessel dissection of target lesion\n* Device thrombosis/occlusion\n* Cardiac perforation requiring percutaneous or open surgical intervention\n* Persistent cardiac arrhythmia requiring a pacemaker'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg', 'timeFrame': 'immediately after deployment', 'description': 'When a pressure gradient provides a reliable hemodynamic variable (e.g., coarctation of the aorta), a reduction in ventricle to arterial or arterial to arterial peak-to-peak pressure gradient to \\< 20 mmHg after stent placement.'}, {'measure': 'Successful Stent Re-dilation at Re-catheterization', 'timeFrame': 'Immediately after re-dilation', 'description': 'Successful stent re-dilation (when indicated) at re-catheterization, defined as an increase in the intra stent angiographic luminal diameter within 2mm of the adjacent native vessel diameter immediately after re-dilation.'}, {'measure': 'Number of Patients With Freedom From Stent Embolization or Migration at 6 Months', 'timeFrame': '6 months', 'description': 'Freedom from stent embolization or migration through 6 months.'}, {'measure': 'Number of Patients With Freedom From Stent Fracture at 6 Months', 'timeFrame': '6 months', 'description': 'Freedom from stent fracture that led to reintervention through 6 months'}, {'measure': 'Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation', 'timeFrame': '90 days post re-dilation', 'description': 'Freedom from non-elective Minima Stent explant at 90-days post re-dilation procedure'}, {'measure': 'Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation', 'timeFrame': 'Immediately after re-dilation', 'description': 'Freedom from procedure- or device-related SAE during re-dilation that results in the following:\n\n* Death\n* Cardiac arrest and/or emergency ECMO cannulation\n* Stroke\n* Limb loss\n* Vessel dissection of target lesion\n* Device thrombosis/occlusion\n* Cardiac perforation requiring percutaneous or open surgical intervention\n* Persistent cardiac arrhythmia requiring a pacemaker'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coarctation of the Aorta', 'Pulmonary Artery Stenosis']}, 'referencesModule': {'references': [{'pmid': '41070410', 'type': 'DERIVED', 'citation': 'Sullivan PM, Zahn EM, Sathanandam S, Morray B, Shahanavaz S, Salavitabar A, Armstrong AK, Porras D, Berman DP. Multicenter Pivotal Trial of the Minima Stent for Vascular Stenosis in Infants and Young Children. Circ Cardiovasc Interv. 2025 Oct 10:e015618. doi: 10.1161/CIRCINTERVENTIONS.125.015618. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria include:\n\n* The subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent\n* Requiring treatment\\* of:\n\n * native, acquired, or recurrent aortic coarctation, or\n * native, acquired, or recurrent pulmonary artery stenosis \\*As defined by the patient's medical team\n* Patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system\n* Adjacent vessel to stenosis measuring \\> or equal to 4 mm\n\nExclusion criteria include:\n\n* Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation\n* History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation\n* Aortic or pulmonary artery aneurysm in the location targeted for treatment\n* Body weight \\< 1.5 kg\n* Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent\n* Target vessels larger or smaller than the Minima System balloon size ranges\n* Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc\n* Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.\n* Currently participating in an investigational drug study or another device study\n* Major or progressive non-cardiac disease resulting in a life expectancy of less than six months\n* Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications\n* Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately pre-medicated"}, 'identificationModule': {'nctId': 'NCT05086016', 'briefTitle': 'Growth Trial: Study of the Renata Minima Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renata Medical'}, 'officialTitle': 'GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent', 'orgStudyIdInfo': {'id': 'PTC-0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All treated', 'description': 'The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).', 'interventionNames': ['Device: Catheterized Stenting']}], 'interventions': [{'name': 'Catheterized Stenting', 'type': 'DEVICE', 'description': 'Catheterized stenting of vascular narrowings.', 'armGroupLabels': ['All treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Le Bonheur Children's", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Darren Berman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renata Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}