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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140010 / PAS001 |
| Date Original Protocol Accepted |
06/19/2015
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| Date Current Protocol Accepted |
06/19/2015
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| Study Name |
IN.PACT SFA Extended f/u study
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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 |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| 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 |
This is the continued the follow-up of the premarket trial. The IN.PACT Superficial Femoral Artery (SFA) trial is a two-phase, global, multicenter, single-blind, randomized (2:1 IN.PACT Admiral drug-coated balloon (DCB) to Percutaneous Transluminal Angioplasty (PTA)) trial. The SFA I and SFA II trials were conducted in Europe and in the United States, respectively.
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| Study Population |
220 subjects treated with the IN.PACT Admiral DCB and 111 subjects treated with PTA in the SFA I and SFA II trials.
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| Sample Size |
Total of 331 subjects: 220 DCB subjects and 111 PTA subjects
It is estimated that from the randomized cohort of the IN.PACT SFA Trial approximately 248 subjects (165 DCB subjects and 83 PTA subjects) will have primary endpoint data at 24 months
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| Key Study Endpoints |
Primary effectiveness endpoint
Primary patency at 24 months
Primary safety endpoint
Freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically- driven target vessel revascularization (CD-TVR) at 24 months
Secondary study endpoints
Through 60 months
-Major Adverse Event Composite and its individual components (All-cause mortality, CD-TVR, major target limb amputation, and thrombosis at the target lesion site).
- Clinically-driven target lesion revascularization (CD-TLR)
- All TLR
At 24 and 36 months
-Primary sustained clinical improvement
-Secondary sustained clinical improvement
-Duplex-defined binary restenosis (peak systolic velocity ratio (PSVR) > 2.4) of the target lesion
-Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion
-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 |
IN.PACT Admiral drug-coated balloon (DCB) group: 220 subjects
Percutaneous Transluminal Angioplasty (PTA) group: 111 subjects
Follow-up rate:
Through 60 months the follow-up rate for each of the study groups was:
IN.PACT Admiral DCB group: 80% (176/220)
PTA group: 85.6% (95/111)
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| Actual Number of Sites Enrolled |
57 sites
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| Patient Follow-up Rate |
Through 60 months the follow-up rate for each of the study groups was:
IN.PACT Admiral DCB group: 80% (176/220)
PTA group: 85.6% (95/111)
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| Final Safety Findings |
Primary Safety Endpoint: Freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically- driven target vessel revascularization (TVR) at 24 months.
-IN.PACT Admiral DCB group: 87.4% (173/198) vs. PTA group: 69.8% (74/106)
Difference: 17.6% (Lower bound of 95% CI: 8.5%, p-value: <0.001 (non-inferiority), 95% CI: 7.7%, 27.5%, p-value: <0.001 (superiority p-value))
Secondary safety endpoints through 60 months:
-Major Adverse Event Composite (including death, major target limb amputation, clinically-driven TVR, and thrombosis):
IN.PACT Admiral DCB group: 42.9% (79/184) vs. PTA group: 48.1% (50/104)
-Death (all-cause):
IN.PACT Admiral DCB group: 15.8% (29/184) vs. PTA group: 9.6% (10/104)
-Clinically-driven TVR:
IN.PACT Admiral DCB group: 29.3% (54/184) vs. PTA group: 40.4% (42/104)
-Major Target Limb Amputation:
IN.PACT Admiral DCB group: 0.5% (1/184) vs. PTA group: 0.0% (0/104)
-Thrombosis:
IN.PACT Admiral DCB group: 2.2% (4/184) vs. PTA group: 4.8% (5/104)
-Clinically-driven target lesion revascularization (TLR):
IN.PACT Admiral DCB group: 25.5% (47/184) vs. PTA group: 35.6% (37/104)
-Any TVR:
IN.PACT Admiral DCB group: 29.9% (55/184) vs. PTA group: 40.4% (42/104)
-Any TLR:
IN.PACT Admiral DCB group: 26.6% (49/184) vs. PTA group: 37.5% (39/104)
It was noted that the difference in TLR rates between the two treatment groups decreased over time, from ~20% at 2 years to ~10% at 5 years
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| Final Effect Findings |
Primary Effectiveness Endpoint: Primary patency at 24 months.
IN.PACT Admiral DCB group: 69.2% (108/156) vs. PTA group: 50.5% (48/95)
Difference (95% CI): Superiority test: 18.7% [6.3%, 31.1%], p-value =0.005.
Primary Sustained Clinical Improvement at 36 months:
IN.PACT Admiral DCB group: 68.7% (114/166) vs. PTA group: 52.6% (51/97)
Difference (95% CI): Superiority test: 16.1% [3.9%, 28.3%], p-value= 0.012.
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| Study Strengths & Weaknesses |
Strengths: This PAS followed through 5 years subjects in SFA trial, the premarket cohort. It met its study goals; the IN.PACT Admiral DCB group showed statistical superiority in the primary effectiveness endpoint against the PTA group. It also met the predefined 10% non-inferiority margin in the primary safety endpoint against the PTA group. In addition to meeting the study goals and the long-term follow-up of 5 years, strengths of this PAS include randomized treatment assignment and a low rate of attrition in both treatment groups, thus minimizing selection bias.
Weakness: The generalizability of the study results to a broader group of patients may be limited since this randomized clinical trial comprised of a selected study population, as it generally occurs in this type of studies. In addition, 150 subjects (45%) included in the trial were from Europe when enrolled in the first phase of the IN.PACT SFA Trial.
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| Recommendations for Labeling Changes |
A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term performance of the device from the pre-market randomized clinical trial.
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