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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P220004 / PAS001 |
| Date Original Protocol Accepted |
11/02/2023
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| Date Current Protocol Accepted |
|
| Study Name |
PALMAZ MULLINS XD Real-World Use PAS
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| Device Name |
PALMAZ MULLINS XD Pulmonary Stent
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, single-arm, multi-center, post-approval study of all consecutive subjects treated with the Palmaz Mullins XD Pulmonary Stent.
The objective of this study is to characterize clinical outcomes and to assess the real-world use of the commercial Palmaz Mullins XD Pulmonary Stent.
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| Study Population |
The study population will contain all consecutive subjects treated with the commercially available Palmaz Mullins XD Pulmonary Stent.
“Consecutive” is defined as a commitment by the participating investigators at each study site to enroll all subjects admitted for non-emergency
treatment of pulmonary artery stenosis who meet eligibility criteria per the IFU and are selected to receive the Palmaz Mullins XD Pulmonary Stent.
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| Sample Size |
Number of subjects: The study will enroll a minimum of 35 subjects and a maximum of 75 subjects or until the end of the 2-year enrollment period has been reached, whichever comes first.
Assumptions for sample size estimation: Sample size is based on assumed enrollment rate over a two year period.
Number of sites: Up to 11 sites
Sites location: In the United States
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| Key Study Endpoints |
Safety Endpoints
Primary: Device or procedure-related, serious adverse events reported through time of hospital discharge, which meet any of the following criteria:
a) Led to a death,
b) 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
c) Other Serious (important) Medical Events
Effectiveness Endpoints
Primary: Patency defined as an increase in stented vessel minimum pulmonary artery diameter by = 50% of the pre-stent diameter determined
by post-implant angiography.
Technical Success defined as:
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.
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| Follow-up Visits and Length of Follow-up |
Length of follow-up is through time of hospital discharge. There will not be follow-up visits after the patient is discharged following the implantation
procedure of the Palmaz Mullins Pulmonary Stent
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