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Percutaneous transluminal angioplasty has historically been the standard in minimally invasive treatment of peripheral artery disease (PAD). In iliac arteries, self-expanding, nitinol stent technology has evolved as an effective treatment of atherosclerotic lesions. BIOFLEX-I evaluates the safety and efficacy of the Astron stent in the iliac arteries.
The BIOFLEX-I study was a prospective, multicenter, non-randomized, single arm, investigational device exemption (IDE) study performed in the United States, Canada, and Europe. Thirty (30) study centers enrolled 161 evaluable study subjects for treatment of de novo or restenotic lesions (≤140mm length) or occlusions (≤100mm length) in common and/or external iliac arteries with reference vessel diameters from 6 to 9mm. The primary endpoint was the composite rate of procedure or stent related major adverse events (MAEs) at 12 months post index procedure. MAEs were defined as 30-day mortality, clinically-indicated target lesion revascularization (TLR) and index limb amputation at 12 months. Results were compared to a pre-specified performance goal based on prior prospective, multicenter studies utilizing nitinol-based, self-expanding stents for the treatment of iliac lesions similar to those in this study. Core laboratories were utilized for independent confirmation of angiography and duplex ultrasound findings. All site reported MAEs were adjudicated by an independent Clinical Events Committee.
For the BIOFLEX-I study of patients with iliac disease treated with the Astron stent, the primary endpoint was met. The 12-month composite endpoint of MAE was 2.1% (3/146) (p<0.001) 95 % CI [0.4%, 5.9%]. The 30 day mortality rate was 0.7% (1/146) 95 % CI [0.0%, 3.8%]. Target lesion revascularization (TLR) rates at 12 months were 1.4% (2/146) 95 % CI [0.2%, 4.5%], and 12-month index limb amputation was 0.0% (0/146) 95 % CI [0.0%, 2.5%]. The secondary endpoint of primary patency was 89.8% (115/128) 95 % CI [83.3%, 94.5%] at 12 months.
The 12-month outcomes of the BIOFLEX-I study for the Astron stent in iliac indications demonstrate a low MAE rate, high primary patency, and a low rate of TLR. This supports the safety and efficacy of the self-expanding, nitinol stent for treatment of atherosclerotic lesions in the iliac arteries.