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

NCT07122518 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2025-08-14

No results posted yet for this study

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.

Conditions

  • Pulmonary Artery Stenosis

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.

Sponsors & Collaborators

  • Congenital Cardiovascular Interventional Study Consortium (CCISC)

    collaborator UNKNOWN

  • Cordis Corporation

    lead INDUSTRY

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07122518 on ClinicalTrials.gov