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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140010 / PAS002 |
| Date Original Protocol Accepted |
06/19/2015
|
| Date Current Protocol Accepted |
06/19/2015
|
| Study Name |
Cont f/u of Sub in SFA Global Clin Prog
|
| Device Name |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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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 |
Prospective cohort study of the continued follow-up of patients enrolled in the IN.PACT superficial femoral artery (SFA) Global Clinical Program (premarket cohorts and the IN.PACT Global Study).
The study population includes all IN.PACT Admiral drug-coated balloon (DCB) subjects enrolled in the IN.PACT SFA Trial, the IN.PACT SFA pharmacokinetic (PK) Sub-study, and the IN.PACT Global Study.
The IN.PACT SFA Trial was designed as a two-phase, global, multicenter, single-blind, randomized (2:1 IN.PACT Admiral DCB to percutaneous transluminal angioplasty (PTA)) trial.
The IN.PACT SFA PK Sub-study was designed to characterize the concentration level and pharmacokinetic parameters of paclitaxel in the systemic circulation over time. The sub-study was conducted concurrently with the IN.PACT SFA II phase of the IN.PACT SFA Trial in the United States.
The IN.PACT SFA Global Study was designed as a prospective, multi- center, single-arm study of consecutively enrolled patients treated for atherosclerotic disease of the SFA and/or
popliteal artery (PA) with the IN.PACT Admiral DCB.
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| Study Population |
The study population includes all IN.PACT Admiral DCB subjects enrolled in the IN.PACT SFA Trial, the IN.PACT SFA PK Sub- study, and the IN.PACT Global Study.
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| Sample Size |
There are at least 1,600 IN.PACT Admiral DCB subjects, including 220 DCB subjects from the IN.PACT SFA Trial, 25 DCB subjects from the IN.PACT SFA PK Sub-study, and 1,400 DCB subjects from the IN.PACT Global Study.
|
| Key Study Endpoints |
Key safety and effectiveness endpoints
Through 60 months
-Major Adverse Event Composite and its individual components (All-cause mortality, clinically-driven target vessel revascularization (CD-TVR), major target limb amputation, and thrombosis at the target lesion)
-Clinically-driven target lesion revascularization (CD-TLR)
-All TLR
-All TVR
-Serious Adverse Events
At 24 and 36 months
- Primary sustained clinical improvement
- Secondary sustained clinical improvement
- Quality of Life assessment
- Walking capacity
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Cohort Subjects Enrolled
On-Label 650
All-Subject 1651
Long Lesion 227
|
| Actual Number of Sites Enrolled |
On-Label IN.PACT SFA I: The first phase of the IN.PACT Admiral
All subject DCB program completed enrollment in Europe with 13
participating clinical sites.
IN.PACT SFA II: The second phase of the IN.PACT
Admiral DCB program completed enrollment in the US with
44 participating clinical sites.
IN.PACT SFA PK Sub-study: Completed enrollment in
the US with nine participating clinical sites.
IN.PACT Global Study: Completed enrollment globally
with 64 participating clinical sites.
Long Lesion 28 non-US investigational sites
|
| Patient Follow-up Rate |
Cohort Follow-up Time Overall Follow-up Compliance %
On-Label 60 Months 86.3
All-Subject 60 Months 85.1
Long Lesion 36 Months 86.7
|
| Final Safety Findings |
Cohort Primary Safety Endpoint
On-Label MAE composite and its individual components (all-cause
All-Subject mortality, CD-TVR, major target limb amputation, and
thrombosis at the target lesion site), CD-TLR, all TVR, all
TLR, and serious adverse events.
Long Lesion Freedom from device and procedure-related death through 30
days post-procedure and freedom from target limb major
amputation and clinically-driven target vessel revascularization
(CD-TVR) within 12 months post-index procedure.
|
| Final Effect Findings |
On-Label Primary sustained clinical improvement, secondary sustained
All-subject clinical improvement, quality of life assessment
by EQ-5D questionnaire, and walking capacity assessment by WIQ.
Long Lesion Primary patency within 12 months post-index procedure,
defined as freedom from clinically-driven target lesion
revascularization (CD-TLR), and freedom from restenosis as
determined by Doppler Ultrasound (DUS) Peak Systolic
Velocity Ratio (PSVR) less than or equal to 2.4.
|
| Study Strengths & Weaknesses |
The study has a patient mortality rate of 16.1% for the Global Registry
Patients at 5 years, and 6.4% for the Long Lesion Patients at 3 years. However, safety and functional
results were as expected at these time points. Additionally, the follow-up period includes a very high
number of patients not eligible for follow-up (e.g., death, withdrawal) in the on-label and all-subject
cohorts. However, of those eligible for follow-up, the rate was 86.3% for on-label and 85.1% for the
all-subject cohort.
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| Recommendations for Labeling Changes |
No labeling changes recommended
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