|
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P190008 / PAS002 |
| Date Original Protocol Accepted |
04/10/2020
|
| Date Current Protocol Accepted |
09/14/2023
|
| Study Name |
New Enrollment IN.PACT AV Access PAS
|
| Device Name |
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
|
| 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 new enrollment IN.PACT AV Access Post Approval Study is a Condition of Approval for the IN.PACT AV device. It is a prospective, non-randomized, multi-center, single-arm post-approval study in the United States. that is intended to assess the long term safety and performance of the
IN.PACT AV DCB in a U.S. population. There are two cohorts. The objectives of the primary cohort is to demonstrate the 1-year infection and infestation rate and the mortality rate out to 5 years. An extended cohort will also be enrolled to obtain real-world experience regarding the rates of infection/infestation and mortality.
|
| Study Population |
Subjects with a de novo or non-stented restenotic obstructive lesion up to 100 mm in length, located in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
|
| Sample Size |
240 subjects will be enrolled at up to 20 clinical sites in the
US, with an expected enrollment period of 18-24 months. In the primary cohort, a sample size of up to 160 patients will be enrolled to ensure 125 patients complete follow-up through 1-year. Up to 80 patients will be evaluated in the extended cohort.
|
| Key Study Endpoints |
Primary Cohort:
The primary cohort is designed to meet a performance goal of 30% for Serious Adverse Events defined as site reported serious adverse events MedDRA coded to the “infection and infestations” SOC through 1-year post-index procedure. The study will also collect information on the mortality rate out to 5 years. The mortality rate through 1 and 2 years post-index procedure will include and exclude COVID-19 related deaths. The mortality rate through 3, 4, and 5 years post-index procedure will use vital status data.
Extended Cohort:
An extended cohort will also be enrolled to obtain real-world experience regarding the rates of infection/infestation and mortality out to 5 years. The mortality rate through 1 and 2 years post-index procedure will include and exclude COVID-19 related deaths. The mortality rate through 3, 4, and 5 years post-index procedure will use vital status data.
|
| Follow-up Visits and Length of Follow-up |
Patients will be followed up to 60 months post-index procedure.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
118 (65 in primary cohort, 53 in extended cohort)
|
| Actual Number of Sites Enrolled |
12
|
| Patient Follow-up Rate |
In the primary cohort, the 6-month follow-up visit compliance was 93.9%, the 12-month visit compliance was 100%, and the 24-month
visit-compliance was 100%. In the extended cohort, follow-up visit compliance is 100% at 6, 12, and 24 months.
|
| Final Safety Findings |
Twenty-three patients (36.5%) in the Primary Cohort experienced one or more SAE. Arteriovenous fistula site complication was
experienced by twelve patients in the Primary Cohort (19.0%). Twenty-nine patients (59.2 %) in the Extended Cohort experienced
one or more SAE. A total of ten deaths have been reported as of the data cutoff date (7 in the Primary Cohort, 3 in the Extended Cohort).
|
| Final Effect Findings |
N/A
|
