Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT07114718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-08-03', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint', 'timeFrame': 'Implant to 30 days', 'description': 'Freedom from death related to the device or implantation procedure or Major Complication related to the device or implantation procedure at 30 days.'}, {'measure': 'Primary Efficacy Endpoint', 'timeFrame': 'Implant to 180 days', 'description': 'Freedom from open surgical intervention to address stent dysfunction in subjects with a Lifeline stent implanted at the earlier of 180 days or the time of stent division or ligation during complete surgical repair or second stage surgery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Ductus Arteriosus Stent', 'pediatric stent', 'Lifeline Stent'], 'conditions': ['Congenital Heart Disease', 'Congenital Heart Disease (CHD)']}, 'descriptionModule': {'briefSummary': 'Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System. The study device is a stent that is designed to maintain patency of the Ductus Arteriosus for children who need blood flow through that part of the heart.', 'detailedDescription': 'Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the LifelineTM Ductus Arteriosus Stent System.\n\nThe purpose of the study is to determine whether the Ductus Arteriosus Stent System demonstrates safety and effectiveness for patients who require ductal patency and merits Food and Drug Administration (FDA) approval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '0 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parental or legal authorized representative provide consent for study enrollment\n2. Infants \\< 6 months of age\n3. Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins\n4. Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm\n\nExclusion Criteria:\n\n1. Active blood stream infection\n2. Active or history of endocarditis\n3. Body weight \\<2.5kg\n4. Gestational age \\<32 weeks at birth\n5. Complete heart block\n6. Total Anomalous Pulmonary Venous Return\n7. Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist\n8. Presence of an aortopulmonary collateral that is expected to require unifocalization\n9. Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)\n10. Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation\n11. Currently participating in an investigational drug study or another device study that would confound the study results\n12. Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure\n13. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)\n14. Patient who is undergoing another transcatheter procedure (e.g., atrial septostomy, aortic arch intervention, or right ventricular outflow tract intervention) during or within 24 hours prior to the ductus arteriosus stenting procedure\n15. Patient who, at the time of enrollment, is deemed not to be a candidate for eventual stage II palliation of single ventricle heart disease, complete surgical repair, nor transcatheter treatment with resultant biventricular circulation\n16. Patient who does not plan to return to the enrolling center or another participating center for stage II palliation, complete surgical repair, or definitive catheterization procedure\n17. Contraindications to peri-procedural anticoagulation\n18. Known to be non-responsive to aspirin or other antiplatelet therapies\n19. Known hypersensitivity or allergy to Nickel\n20. Known hypersensitivity to contrast media that cannot be adequately pre-medicated'}, 'identificationModule': {'nctId': 'NCT07114718', 'briefTitle': 'Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Starlight Cardiovascular Inc'}, 'officialTitle': 'Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study', 'orgStudyIdInfo': {'id': 'G250132'}, 'secondaryIdInfos': [{'id': '2R44HL158304-04A1', 'link': 'https://reporter.nih.gov/quickSearch/2R44HL158304-04A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm - Treatment', 'description': 'Treatment with the Lifeline Ductus Arteriosus Stent', 'interventionNames': ['Device: Ductus Arteriosus Stent']}], 'interventions': [{'name': 'Ductus Arteriosus Stent', 'type': 'DEVICE', 'otherNames': ['Stent', 'Pediatric Stent'], 'description': 'The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.', 'armGroupLabels': ['Single Arm - Treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mary Beth Tate, BSBE-MBA', 'role': 'CONTACT', 'email': 'marybeth.tate@globalmedicaldeviceconsultants.com', 'phone': '734-709-2080'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Starlight Cardiovascular Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}