REALPASS
A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)
Sponsor study identifier
observational
35
1 country
8
Study Start
June 23, 2026
Actual (reported)Primary Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2, 2025
Actual (reported)August 14, 2025
Actual (reported)June 23, 2026
Actual (reported)June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)
1. Successful access, delivery and retrieval of the device delivery system, 2. Deployment and correct positioning of the device in the intended location, and 3. 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/study completion, usually within ~48 hours from end time of index procedure
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)
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: 1. Led to a death, 2. Led to a serious deterioration in health of the subject, that either resulted in 1. Life-threatening illness or injury, or 2. Hospitalization (initial or prolonged) or 3. Disability or permanent impairment of a body structure or a body function or 4. Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. Other Serious (important) Medical Events
Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure
Baseline Characteristics - Demographics
Pre-procedure baseline
Baseline Characteristics - Medical History
Pre-procedure baseline
Baseline Characteristics - Clinical History: Weight
Pre-procedure baseline
All enrolled subjects are treated with the 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
UC Davis Children's Hospital
Sacramento, California, 95817, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Children's Hospital of Michigan
First Submitted
July 2, 2025
First Posted
August 14, 2025
Study Start
June 23, 2026
Actual (reported)Primary Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Minima Stent System Post- Approval Study (PAS)
Detroit, Michigan, 48201, United States
St Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68114, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
UMPC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 2, 2026
Record last verified: 2026-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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