Angioplasty of lower extremity arteries with calcification may result in flow limiting dissection requiring bail-out stenting with unfavorable long-term outcomes. Vessel preparation prior to angioplasty may improve immediate results of the angioplasty and long-term patency. This prospective study assessed the 12-month outcomes of patients who underwent novel vessel preparation catheter, the FLEX Vessel Prep™ System (FLEX VP), prior to drug-coated balloon angioplasty (DCB-PTA).

This investigator-initiated single-arm prospective trial enrolled patients with symptomatic lower extremity peripheral artery disease with de novo, restenotic, or in-stent stenosis of the superficial femoral or popliteal arteries. Target lesions were prepared using FLEX VP that created 12 longitudinal micro-incisions before drug-coated balloon angioplasty.

Forty-three lesions in 41 patients were treated in this study with an average lesion length of 118 mm (10 - 291 mm), average stenosis of 82% (40-100%) and an occlusion rate of 27.9% with an average occlusion length of 89 mm (10-272 mm). Calcification was observed in 85.7% of the lesions with 66.7% of lesions demonstrating grade 3 or 4 of the Peripheral Arterial Calcification Scoring System. After FLEX VP and DCB-PTA, 92.7% of patients were absent of flow-limiting dissections. Stenting occurred in 39% (16/41) patients (median stent length 40mm) for residual stenosis (15 patients) and flow-limiting dissection (1 patient). There was one death prior to the 12-month follow-up, not related to the index procedure. Freedom from clinically-driven target lesion revascularization at 12 months was 97.5% (39/40). Rutherford classification shifted from 41.5% Class >3 at baseline to 95% Class <1 at 12 months. There were no amputations at 12-months.

Vessel preparation with longitudinal micro-incisions of complex and calcified lesions prior to angioplasty was associated with few flow-limiting dissections. The majority of stents were placed to treat focal residual stenosis, using the shortest available stent length at time of the study (40mm) for the majority. Only one stent was needed to treat a flow-limiting dissection. The 97.5% freedom from CDTLR and symptom relief at 12 months suggest that vessel preparation via FLEX VP provides value in maintaining long-term outcomes in patients with highly calcified SFA or popliteal lesions.