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RECRUITING
NCT07122518

Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis

Sponsor: Cordis US Corp.

View on ClinicalTrials.gov

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 - Any

Study Type

OBSERVATIONAL

Enrollment

35

Start Date

2026-06-23

Completion Date

2028-06

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

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.

Locations (8)

UC Davis Children's Hospital

Sacramento, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

St Louis Children's Hospital

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Children's Hospital Medical Center

Cincinnati, Ohio, United States

UMPC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States