A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)
Cordis US Corp.
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.
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
\- 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.
Interventions
- DevicePALMAZ 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 HospitalSacramento, California
- Children's Healthcare of AtlantaAtlanta, Georgia
- Children's Hospital of MichiganDetroit, Michigan
- St Louis Children's HospitalSt Louis, Missouri
- University of Nebraska Medical CenterOmaha, Nebraska
- Children's Hospital Medical CenterCincinnati, Ohio