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.
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.
Study Type
OBSERVATIONAL
Enrollment
75
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.
Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)
1. Successful access, delivery and retrieval of the device delivery system, 2. Deployment and correct positioning of the device in the intended location, and 3. No need for additional, unplanned surgery or re-intervention related to the device or access procedure.
Time frame: Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure
Patency (Angiographically-determined increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter)
Increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter determined by post-implant angiography.
Time frame: Index procedure (start time to end time)
Safety Outcome (Incidence of Treatment-Emergent Serious Adverse Events)
Device or procedure-related, serious adverse events reported through time of hospital discharge, which meet any of the following criteria: 1. Led to a death, 2. Led to a serious deterioration in health of the subject, that either resulted in 1. Life-threatening illness or injury, or 2. Hospitalization (initial or prolonged) or 3. Disability or permanent impairment of a body structure or a body function or 4. Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. Other Serious (important) Medical Events
Time frame: Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure
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