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

Cordis

Status: Not yet enrolling

Conditions: Pulmonary Artery Stenosis

Treatments: Device: PALMAZ MULLINS XD™ Pulmonary Stent

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07122518

P23-8501

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

75 participants in 1 patient group

Palmaz Mullins XD™ Treatment

Description:

All enrolled subjects are treated with the PALMAZ MULLINS XD™ Pulmonary Stent

Treatment:

Device: PALMAZ MULLINS XD™ Pulmonary Stent