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General |
Study Status |
Completed |
Application Number / Requirement Number |
P140010 / PAS002 |
Date Original Protocol Accepted |
06/19/2015
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Date Current Protocol Accepted |
06/19/2015
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Study Name |
Cont f/u of Sub in SFA Global Clin Prog
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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
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
New Data Collection
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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.
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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
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Follow-up Visits and Length of Follow-up |
5 years
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
Cohort Subjects Enrolled On-Label 650 All-Subject 1651 Long Lesion 227
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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
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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
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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.
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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.
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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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