Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate

To report our experience in treating severely claudicant patients, employing a "nitinol-constrained" balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA-USA) before drug-coated balloon (DCB) in a standardized protocol.Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up.Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (p = 0.725). CTO length impacted early results: in cases of CTOs 150 mm, PP was 100%, while in CTOs 150 mm, it was 83.3% (p = 0031). ABI at 12-month was significantly higher with respect to preoperative values (p 0.001).In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.