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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160025 / PAS001 |
| Date Original Protocol Accepted |
03/23/2017
|
| Date Current Protocol Accepted |
08/07/2017
|
| Study Name |
BIOFLEX-I PAS
|
| Device Name |
ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, non-randomized, multi-center follow-up of the BIOFLEX-I pivotal study (G100002)
|
| Study Population |
The study population included subjects greater than or equal to 18 years old with life-style limiting claudication or rest pain, with an ABI less than or equal to 0.9 (resting or exercise). Inclusion criteria included one de novo, restenotic or occluded femoropopliteal lesion, OR two de novo , restenotic or occluded lesions representing one femoropopliteal indication and one iliac indication on contralateral limbs (i.e., one lesion per limb). Lesion length was specified as less than or equal to 190 mm (if de novo or restenotic) or less than or equal to 100mm (if occluded), with target vessel reference diameter: 2.5 to 6 mm (SFA/PPA) by visual estimate and with angiographic evidence of atleast one distal vessel runoff to the foot.
|
| Sample Size |
A total of 280 subjects were active at the time of the 12-month primary endpoint assessment. The long-term post-market analysis of the Pulsar stent group will include a minimum of 202 subjects (238 subjects x 0.85) at 36 months and a minimum of 238 subjects (280 subjects x 0.85) at 24 months. This calculation accounts for a 15% annual attrition rate due to premature exits including subject withdrawal and lost to follow (LTF) and excluding deaths.
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| Key Study Endpoints |
The primary endpoint to be assessed is freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months, as defined by the protocol. The secondary endpoints to be assessed include the following:
Freedom from a composite of clinically-driven TLR and index limb amputation at 24 months.
Major adverse events (MAE) rate (30-day mortality, clinically-driven TLR, and index limb amputation) and their components at 24 months.
MAE rate (30-day mortality, clinically driven TLR, and index limb amputation) and their components at 36 months.
Target lesion revascularization (TLR) rate at 24 months.
Target lesion revascularization (TLR) rate at 36 months.
Stent fracture rate at 24 months.
Stent fracture rate at 36 months.
Adverse events rates at 36 months.
|
| Follow-up Visits and Length of Follow-up |
36 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
782
|
| Actual Number of Sites Enrolled |
43
|
| Patient Follow-up Rate |
1, 6, 12, 24, and 36 months
|
| Final Safety Findings |
Primary- Freedom from clinically-driven target lesion revascularization (TLR) and index limb amputation: 78.2% (201/257), 95% CI [72.7%, 83.1%] at 36 months
|
| Final Effect Findings |
Primary – primary patency of the Astron Pulsar stent at 12 months: 66.8% (179/268), 95% CI [60.8%, 72.5%]
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| Study Strengths & Weaknesses |
NONE
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| Recommendations for Labeling Changes |
Yes, update to include PAS data
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