[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602362":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":59,"studyPopulation":60,"armGroups":61,"interventions":67,"overallOfficials":21,"centralContacts":73,"locations":21,"responsibleParty":79,"collaborators":81,"id":85,"slug":21,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":21,"maxAge":93,"enrollmentInfo":94,"targetDuration":21,"studyType":97,"phases":21,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":105,"whyStopped":21,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":21},{"fullName":5,"class":6},"Cordis US Corp.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":22},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery\u002Fre-intervention)","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.","Start time of index procedure through time of discharge\u002Fstudy completion, usually within ~48 hours from end time of index procedure",{"measure":14,"description":15,"timeFrame":16},"Patency (Angiographically-determined increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter)","Increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter determined by post-implant angiography.","Index procedure (start time to end time)",{"measure":18,"description":19,"timeFrame":20},"Safety Outcome (Incidence of Treatment-Emergent Serious Adverse Events)","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","Time of enrollment (device implant during index procedure) through time of discharge\u002Fstudy completion, usually within ~48 hours from end time of index procedure",null,[23,27,30,33,36,39,43,47,50,53],{"measure":24,"description":25,"timeFrame":26},"Baseline Characteristics - Demographics","Demographics (age, gender)","Pre-procedure baseline",{"measure":28,"description":29,"timeFrame":26},"Baseline Characteristics - Medical History","Medical History (diagnosis, prior surgery)",{"measure":31,"description":32,"timeFrame":26},"Baseline Characteristics - Clinical History: Weight","Clinical History (weight in kg)",{"measure":34,"description":35,"timeFrame":26},"Baseline Characteristics - Clinical History: Height","Clinical History (height in cm)",{"measure":37,"description":38,"timeFrame":26},"Baseline Characteristics - Clinical History: Body Surface Area","Clinical History (body surface area in square meters)",{"measure":40,"description":41,"timeFrame":42},"Target Vessel Characteristics (Stenosis type and location, lesion length and target vessel diameters)","Stenosis type and location, lesion length and target vessel diameters","Angiography during index procedure",{"measure":44,"description":45,"timeFrame":46},"Procedural Characteristics (occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure)","Occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure","Index procedure",{"measure":48,"description":49,"timeFrame":46},"Device Characteristics - Dimensions of PALMAZ MULLINS XD™ Pulmonary Stent","PALMAZ MULLINS XD™ Pulmonary Stent dimensions",{"measure":51,"description":52,"timeFrame":46},"Device Characteristics - Balloon Manufacturer\u002FModel and Dimensions","Balloon manufacturer\u002Fmodel and dimensions",{"measure":54,"description":55,"timeFrame":46},"Device Characteristics - Sheath Manufacturer\u002FModel and Dimensions","Sheath manufacturer\u002Fmodel and dimensions",{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":57,"timePerspective":58,"maskingInfo":21},"COHORT","PROSPECTIVE","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.","Subjects with pulmonary artery stenosis who are candidates for treatment with the PALMAZ MULLINS XD™ Pulmonary Stent according to clinical guidelines and\u002For the operators' judgement will be eligible for enrollment in this study.",[62],{"label":63,"type":21,"description":64,"interventionNames":65},"Palmaz Mullins XD™ Treatment","All enrolled subjects are treated with the PALMAZ MULLINS XD™ Pulmonary Stent",[66],"Device: PALMAZ MULLINS XD™ Pulmonary Stent",[68],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":21},"DEVICE","PALMAZ MULLINS XD™ Pulmonary Stent","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.",[63],[74],{"name":75,"role":76,"phone":77,"phoneExt":21,"email":78},"Jenny Jimenez","CONTACT","1 669-255-4123","jenny.jimenez@cordis.com",{"type":80,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[82],{"name":83,"class":84},"Congenital Cardiovascular Interventional Study Consortium (CCISC)","UNKNOWN","100602362",false,"NCT07122518","Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis","A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)","REALPASS","\\- Subjects \\*should\\* meet criteria as per the list of indications\u002Fcontraindications in the Instructions for Use, though all subjects treated with PALMAZ MULLINS XD™ Pulmonary Stent will be considered eligible and enrolled.","ALL","21 Years",{"count":95,"type":96},75,"ESTIMATED","OBSERVATIONAL","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.",[100],"Pulmonary Artery Stenosis",[102,103,104],"pulmonary artery stenosis","Pulmonary Artery Stenting","PALMAZ MULLINS XD Pulmonary Stent","NOT_YET_RECRUITING","2025-08-07",{"date":108,"type":109},"2025-08-14","ACTUAL",{"date":111,"type":96},"2025-12",{"date":113,"type":96},"2027-12",{"name":5,"class":6}]