Role of the AngioSculpt scoring balloon catheter for the treatment of femoro-popliteal disease: 1-year results from the MASCOT Trial




Background


The AngioSculpt (ASC) incorporates a flexible nitinol scoring element consisting of three to four rectangular struts which encircle a balloon. Prior studies demonstrated that the ASC is effective in treating complex fibro-calcific lesions in coronary and infrapopliteal arteries.




Methods


Patients with ≥50% diameter stenosis (DS) involving the femoro-popliteal arteries (diameter 4.5–6.0 mm, lesion length ≤8 cm) and debilitating claudication or CLI (Rutherford Class 2–5) were treated with the ASC at three European sites and followed at 30 days and 12 months including duplex ultrasound (DU). The primary efficacy end point was 12-month patency of the target lesion by DU, and the primary safety end point was MACE-free survival at 30 days.




Methods


Patients with ≥50% diameter stenosis (DS) involving the femoro-popliteal arteries (diameter 4.5–6.0 mm, lesion length ≤8 cm) and debilitating claudication or CLI (Rutherford Class 2–5) were treated with the ASC at three European sites and followed at 30 days and 12 months including duplex ultrasound (DU). The primary efficacy end point was 12-month patency of the target lesion by DU, and the primary safety end point was MACE-free survival at 30 days.

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Nov 16, 2017 | Posted by in CARDIOLOGY | Comments Off on Role of the AngioSculpt scoring balloon catheter for the treatment of femoro-popliteal disease: 1-year results from the MASCOT Trial

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