Not currently recruiting at University of California Health

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

a study on Pulmonary Artery Stenosis

Summary

Location
at UC Davis
Dates
study started
study ends around
Principal Investigator
by Frank Ing, MD (ucdavis)

Description

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)

Details

The clinical study is a prospective, single-arm, multi-center, post-approval study of all consecutive subjects treated with the PALMAZ MULLINS XD™ Pulmonary Stent. The study will enroll a minimum of 35 subjects and a maximum of 75 subjects in up to 11 U.S sites or until the end of the 2-year enrollment period has been reached, whichever comes first.

The study will collect the performance and safety data of the PALMAZ MULLINS XD™ Pulmonary Stent through time of hospital discharge.

Keywords

Pulmonary Artery Stenosis, Pulmonary Artery Stenting, PALMAZ MULLINS XD Pulmonary Stent, PALMAZ MULLINS XD™ Pulmonary Stent

Eligibility

  • Subjects *should* meet criteria as per the list of indications/contraindications in the Instructions for Use, though all subjects treated with the PALMAZ MULLINS XD™ Pulmonary Stent will be considered eligible and enrolled.

Locations

  • UC Davis Children's Hospital not yet accepting patients
    Sacramento California 95817 United States
  • University of Nebraska Medical Center accepting new patients
    Omaha Nebraska 68114 United States
  • Children's Hospital Medical Center accepting new patients
    Cincinnati Ohio 45229 United States

Lead Scientist at University of California Health

  • Frank Ing, MD (ucdavis)
    Professor, MED: Pediatrics, School of Medicine. Authored (or co-authored) 104 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Cordis US Corp.
ID
NCT07122518
Study Type
Observational
Participants
Expecting 35 study participants
Last Updated