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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P170003 / PAS002 |
| Date Original Protocol Accepted |
02/26/2018
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| Date Current Protocol Accepted |
12/16/2021
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| Study Name |
New Enrollment PAS Registry
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| Device Name |
LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010
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| Clinical Trial Number(s) |
NCT02440022
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| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
To demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB for treatment of dysfunctional AV fistulae located in the arm in a heterogeneous patient population in a real world clinical practice.
A prospective, global multicenter, single arm, post-approval registry study of newly enrolled patients.
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| Study Population |
Subjects presenting with clinical and hemodynamic abnormalities in arteriovenous fistulae located in the arm who meet all inclusion criteria and none of the exclusion criteria.
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| Sample Size |
A total of 213 subjects will be enrolled at a minimum of 15 and a maximum of 30 U.S. and International sites. Approximately 50% of subjects enrolled and study sites will be from the U.S.
Based on a TLPP rate of 71.4%, a non-inferiority margin of 10%, a 10% drop-out rate and one-sided exact binomial test p = 0.05, sample size of 213 provide 90% power for evaluating the primary effectiveness hypothesis comparing 61.4% PG.
Based a primary safety endpoint rate of 95% (pivotal trial), a non-inferiority margin of 6%, and one-sided exact binomial test p = 0.05, sample size of 213 will provide 95% power evaluating the primary safety hypothesis comparing to 89% PG.
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| Key Study Endpoints |
Primary Safety Endpoint:
Freedom from any serious adverse event(s) involving the AV access circuit through 30 days
Primary Effectiveness Endpoint:
TLPP through 6 months
defined as the interval following index procedure until clinically-driven reintervention of the target lesion or access thrombosis, through 6 months
Secondary Safety Endpoints:
1. Freedom from any serious adverse event(s) involving the AV access circuit through 6, 12, 18 and 24 months
2. Rate of device and procedure related adverse events assessed at 6, 12, 18 and 24 months
Secondary Effectiveness Endpoints:
1. TLPP evaluated at 12, 18 and 24 months
2. Number of reinterventions to maintain target lesion patency at 6, 12, 18 and 24 months
3. Time to loss of Target Lesion Primary Patency (i.e. time between index procedure to the first loss of patency)
4. Access Circuit Primary Patency (ACPP) evaluated at 6, 12, 18 and 24 months
5. Number of reinterventions to maintain access circuit patency at 6, 12, 18 and 24 months
6. Device, Procedural and Clinical Success
7. Abandonment of permanent access in the index extremity at 6, 12, 18 and 24 months
8. Secondary Patency of the Access Circuit at 6, 12, 18 and 24 months
9. Time to loss of target lesion secondary patency following DCB (i.e. time between first reintervention with a DCB to the next loss of patency)
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| Follow-up Visits and Length of Follow-up |
24 months
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| Interim or Final Data Summary |
| Interim Results |
Safety Results: N/A
Effectiveness Results
In accordance with the study protocol, an interim analysis report will be provided to FDA after enrollment is completed and the last subject has completed the 6-month follow-up.
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| Actual Number of Patients Enrolled |
134
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| Actual Number of Sites Enrolled |
18 sites have enrolled subjects
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| Patient Follow-up Rate |
Rate:
95/105 (90.5%) completed 6- month follow-up visit (6 pending)
66/69 (95.7%) completed 12-month follow-up visit (2 pending)
50/56 (89.3%) completed 18-month follow-up visit (6 pending)
27/34 (79.4%) completed 24-month follow-up visit (7 pending)
27/134 subjects have discontinued the study (1 withdrawal, 26 death)
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