Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT07122518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071079', 'term': 'Stenosis, Pulmonary Artery'}], 'ancestors': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline Characteristics - Demographics', 'timeFrame': 'Pre-procedure baseline', 'description': 'Demographics (age, gender)'}, {'measure': 'Baseline Characteristics - Medical History', 'timeFrame': 'Pre-procedure baseline', 'description': 'Medical History (diagnosis, prior surgery)'}, {'measure': 'Baseline Characteristics - Clinical History: Weight', 'timeFrame': 'Pre-procedure baseline', 'description': 'Clinical History (weight in kg)'}, {'measure': 'Baseline Characteristics - Clinical History: Height', 'timeFrame': 'Pre-procedure baseline', 'description': 'Clinical History (height in cm)'}, {'measure': 'Baseline Characteristics - Clinical History: Body Surface Area', 'timeFrame': 'Pre-procedure baseline', 'description': 'Clinical History (body surface area in square meters)'}, {'measure': 'Target Vessel Characteristics (Stenosis type and location, lesion length and target vessel diameters)', 'timeFrame': 'Angiography during index procedure', 'description': 'Stenosis type and location, lesion length and target vessel diameters'}, {'measure': 'Procedural Characteristics (occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure)', 'timeFrame': 'Index procedure', 'description': 'Occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure'}, {'measure': 'Device Characteristics - Dimensions of PALMAZ MULLINS XD™ Pulmonary Stent', 'timeFrame': 'Index procedure', 'description': 'PALMAZ MULLINS XD™ Pulmonary Stent dimensions'}, {'measure': 'Device Characteristics - Balloon Manufacturer/Model and Dimensions', 'timeFrame': 'Index procedure', 'description': 'Balloon manufacturer/model and dimensions'}, {'measure': 'Device Characteristics - Sheath Manufacturer/Model and Dimensions', 'timeFrame': 'Index procedure', 'description': 'Sheath manufacturer/model and dimensions'}], 'primaryOutcomes': [{'measure': 'Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)', 'timeFrame': 'Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure', 'description': '1. Successful access, delivery and retrieval of the device delivery system,\n2. Deployment and correct positioning of the device in the intended location, and\n3. No need for additional, unplanned surgery or re-intervention related to the device or access procedure.'}, {'measure': 'Patency (Angiographically-determined increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter)', 'timeFrame': 'Index procedure (start time to end time)', 'description': 'Increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter determined by post-implant angiography.'}, {'measure': 'Safety Outcome (Incidence of Treatment-Emergent Serious Adverse Events)', 'timeFrame': 'Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure', 'description': 'Device or procedure-related, serious adverse events reported through time of hospital discharge, which meet any of the following criteria:\n\n1. Led to a death,\n2. Led to a serious deterioration in health of the subject, that either resulted in\n\n 1. Life-threatening illness or injury, or\n 2. Hospitalization (initial or prolonged) or\n 3. Disability or permanent impairment of a body structure or a body function or\n 4. Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function\n3. Other Serious (important) Medical Events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pulmonary artery stenosis', 'Pulmonary Artery Stenting', 'PALMAZ MULLINS XD Pulmonary Stent'], 'conditions': ['Pulmonary Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the clinical investigation is to characterize clinical outcomes and to assess the real-world use of the commercial PALMAZ MULLINS XD™ Pulmonary Stent.', 'detailedDescription': 'The clinical study is a prospective, single-arm, multi-center, post-approval study of all consecutive subjects treated with the PALMAZ MULLINS XD™ Pulmonary Stent. The study will enroll a minimum of 35 subjects and a maximum of 75 subjects in up to 11 U.S sites or until the end of the 2-year enrollment period has been reached, whichever comes first.\n\nThe study will collect the performance and safety data of the PALMAZ MULLINS XD™ Pulmonary Stent through time of hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Subjects with pulmonary artery stenosis who are candidates for treatment with the PALMAZ MULLINS XD™ Pulmonary Stent according to clinical guidelines and/or the operators' judgement will be eligible for enrollment in this study.", 'healthyVolunteers': False, 'eligibilityCriteria': '\\- Subjects \\*should\\* meet criteria as per the list of indications/contraindications in the Instructions for Use, though all subjects treated with PALMAZ MULLINS XD™ Pulmonary Stent will be considered eligible and enrolled.'}, 'identificationModule': {'nctId': 'NCT07122518', 'acronym': 'REALPASS', 'briefTitle': 'Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)', 'orgStudyIdInfo': {'id': 'P23-8501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Palmaz Mullins XD™ Treatment', 'description': 'All enrolled subjects are treated with the PALMAZ MULLINS XD™ Pulmonary Stent', 'interventionNames': ['Device: PALMAZ MULLINS XD™ Pulmonary Stent']}], 'interventions': [{'name': 'PALMAZ MULLINS XD™ Pulmonary Stent', 'type': 'DEVICE', 'description': 'The PALMAZ MULLINS XD™ Pulmonary Stent is indicated for the non-emergency treatment of pulmonary artery stenosis in pediatric patients who are at least 10kg in weight with two ventricle anatomy. The PALMAZ MULLINS XD™ Pulmonary Stent is a balloon-expandable, laser cut stent made from 316L stainless steel tubing. The stent is supplied unmounted and in five (5) nominal unexpanded lengths: 19 mm, 25 mm, 29 mm, 39 mm, and 59 mm.', 'armGroupLabels': ['Palmaz Mullins XD™ Treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jenny Jimenez', 'role': 'CONTACT', 'email': 'jenny.jimenez@cordis.com', 'phone': '1 669-255-4123'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Congenital Cardiovascular Interventional Study Consortium (CCISC)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}