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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140010 S015/ PAS001 |
| Date Original Protocol Accepted |
12/06/2016
|
| Date Current Protocol Accepted |
|
| Study Name |
Surveillance Post Market Registry
|
| Device Name |
IN PACT(TM) ADMIRAL(TM) PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
To assess the long-term safety and performance of the IN.PACT Admiral DCB in a U.S. population for the treatment of in-stent restenosic (ISR) lesions in the superficial femoral and popliteal arteries.
Prospective, non-randomized, multi-center, single-arm post-market registry
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| Study Population |
Patients from the U.S. with ISR lesions in the superficial femoral and popliteal arteries who have symptoms of claudication and/or rest pain (Rutherford Class 2, 3, or 4) who were entered into the VQI PVI Registry and met all other inclusion and exclusion criteria.
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| Sample Size |
300 patients from the SVS VQI Registry, treated with the IN.PACT Admiral DCB per the standard of care, will be extracted consecutively and analyzed to evaluate the safety and performance of the IN.PACT Admiral DCB in a U.S. population for the treatment of ISR lesions in the femoropopliteal artery.
According to literature research on the performance of DCB in the treatment of ISR femoropopliteal lesions, the 12-month TLR rate for IN.PACT Admiral DCB treatment is expected to be 16%. Assuming 10% attrition at the 12-month follow-up, with 270 evaluable patients, the precision of the assumed 16% point estimate can be assessed by calculating the difference from the 1-sided 95% upper confidence limit. This difference, or margin of error, is calculated to be 4.1%.
|
| Key Study Endpoints |
Primary:
Target lesion revascularization (TLR) within 12 months post-index procedure.
Secondary:
1. All-cause mortality at 12 months and 24 months.
2. Target lesion revascularization (TLR) at 24 months.
3. Target vessel revascularization (TVR) at 12 months and 24 months.
4. Major target limb amputation at 12 months and 24 months.
|
| Follow-up Visits and Length of Follow-up |
36 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
300
|
| Actual Number of Sites Enrolled |
50
|
| Patient Follow-up Rate |
78%
|
| Final Safety Findings |
Primary Safety Endpoint:
Target lesion revascularization (TLR) within 12 months post-index
procedure = 10.1% (28/276); Kaplan-Meier estimate of 10.2% with a 95%
confidence interval of [7.1%, 14.5%].
Secondary Safety Endpoints:
• All-cause mortality at 12, 24, and 36 months = 4.7% (14/299),
10.7% (32/298), and 15.5% (45/291), respectively
• Target lesion revascularization at 24 and 36 months = 29.2%
(71/243) and 45.9% (89/194)
• Target vessel revascularization at 12, 24, and 36 months =
12.0% (33/276), 33.3% (82/246), and 49.5% (99/200),
respectively
• Major target limb amputation at 12, 24, and 36 months = 0.4%
(1/275), 1.3% (3/237), and 1.7% (3/173), respectively
|
| Final Effect Findings |
Technical success, defined as successful deployment of the balloon
without resulting in occlusion and having residual stenosis 30%
and resting systolic pressure gradient < 10 mmHg (if measured), was
achieved in 98.7% (296/300) of patients
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| Study Strengths & Weaknesses |
Strengths:
This PAS followed subjects through 3 years in a real-world, registry, setting. The trial met its study goals and results demonstrate long-term safety and effectiveness of the IN.PACT Admiral DCB in the treatment of in-stent restenosis lesions in the superficial femoral and popliteal arteries up to 36-months follow-up post-index procedure.
Weaknesses:
The study lacked a comparison group. There was less than 80% patient follow up rate at 3-years. The compliance data did not include "lost to follow-up" metrics.
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| Recommendations for Labeling Changes |
A labeling update will be requested to include the 3 year data to
support treatment of in-stent restenotic lesio
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