Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET 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 - 21 Years

Study Type

OBSERVATIONAL

Enrollment

75

Start Date

2025-12

Completion Date

2027-12

Last Updated

2025-08-14

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.