|
|
| General |
| Study Status |
Ongoing |
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 |
| Interim Results |
Safety Results
The following results are based on available data and are subject to change as new data becomes available. These results are cumulative over the total study duration so far.
Fifty-five (55) patients (30.9%) in the Primary Cohort experienced one or more SAE. Arteriovenous fistula site complication was experienced by twenty-two (22) patients (12.4%). Forty-nine (49) patients (55.1%) in the Extended Cohort experienced one or more SAE. The most frequent reported SAEs were Injury, poisoning and procedural complications (31.5%). A total of thirty-three (33) deaths have been reported as of the data cutoff date. Twenty (20) of the deaths were in the Primary Cohort and thirteen (13) of the deaths were in the Extended Cohort.
Effectiveness Results
The following effectiveness results are from the primary cohort. Follow-up was completed on 25% (40/160) of the primary cohort study subjects out to 12months. Preliminary estimates of the effectiveness results are provided based upon available data; updates will be made as additional data is available.
Target Lesion Primary Patency KM Estimate at 12 Months: 73.5% (17 events)
Access Circuit Primary Patency KM Estimate at 12 Months: 64.7% (24 events)
Cumulative Target Lesion Revascularizations KM Estimate at 12 Months: 26.5% (18 events)
Cumulative Access Circuit Thromboses KM Estimate at 12 Months: 6.2% (4 events)
Number of Interventions Required to Maintain Target Lesion Patency Estimate through 12 Months: 0.2 ± 0.6 (171 subjects)
Number of Interventions Required to Maintain Access Circuit Patency Estimate through 12 Months: 0.3 ± 0.9 (171 subjects)
|
| Actual Number of Patients Enrolled |
254 (160 in primary cohort, 80 in extended cohort, 14 exited)
|
| Actual Number of Sites Enrolled |
17
|
| Patient Follow-up Rate |
Primary Cohort | Extended Cohort
6 Months: 98.9% (89/90) | 98.5% (66/67)
12 Months: 100% (40/40) | 100% (36/36)
24 Months: 100% (15/15) | 100% (10/10)
|
| Final Effect Findings |
N/A
|
