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|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P140032 / PAS001 |
| Date Original Protocol Accepted |
07/27/2018
|
| Date Current Protocol Accepted |
|
| Study Name |
Post-Approval Study
|
| Device Name |
Implantable System for Remodulin
|
| Clinical Trial Number(s) |
NCT01321073
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The ISR PAS is a prospective, open-label, observational, multi-center study. 50 newly implanted US subjects will be followed for five years.
Primary Objectives:
To estimate the freedom from catheter-related complications through 5 years post-implant.
To estimate the freedom from ISR pump-related complications through 5 years post implant.
Ancillary Objective
The ancillary objective is descriptive in nature and is intended to gain additional information about the performance of the ISR pump: Plot pump fluid delivery accuracy ratio over time and compare to the intended market-release labeling describing flow rate accuracy performance expected versus refill number.
|
| Study Population |
Patients intended to be implanted with an ISR are eligible for enrollment into the ISR PAS.
|
| Sample Size |
50
|
| Key Study Endpoints |
The endpoint of this objective is catheter-related complications.
If an adverse event indicates that there is unknown relatedness to the catheter, and the event is classified as a complication, it will be counted as a catheter-related complication. Additionally, in the event of a pneumothorax being adjudicated by the CEC as procedure-related, and the event is classified as a complication, it will count toward the primary objective. A patency test for suspected occlusion or elective removal of the implanted system will not be considered a complication.
The endpoint of this objective is pump complications.
Pump-related complications will be defined as any adverse device event that results in death, involves any termination of significant device function, or requires an invasive intervention. A patency test for suspected occlusion, pump refill, elective change-out of the pump during a catheter replacement/revision, or elective removal of implanted system will not be considered a complication.
Plot pump fluid delivery accuracy ratio over time and compare to the intended market-release labeling describing flow rate accuracy performance expected versus refill number.
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| Follow-up Visits and Length of Follow-up |
5 years
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