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Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
Sponsor: Cordis US Corp.
Summary
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.
Official title: A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)
Key Details
Gender
All
Age Range
Any - 21 Years
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2025-12
Completion Date
2027-12
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
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.