Table 1 Summary of evidence of use of sirolimus coated balloons
Study | Aims/Findings |
|---|---|
SCB in peripheral vasculature | |
NCT02941224 (Zeller et al. 2020) | Prospective, single-arm, open-label, multi-center study of 50 patients with femoropopliteal lesions treated with Selution SLR™ demonstrating 88.4% primary patency, 91.2% freedom from restenosis and 85% freedom from TLR at 12 months. |
PRESTIGE (Tang et al. 2021a) | Prospective, single-arm, multi-investigator, single-center study of 25 patients with CLTI treated with Selution SLR™ demonstrating 100% technical success, 81.5% primary patency at 6 months and 8.3.% freedom from clinically driven TLR. |
XTOSI (Choke et al. 2021) | Prospective, single-arm, open-label, single-center study of 50 patients with PAD treated with MagicTouch™ demonstrating 100% technical and device success, 89.7% 12-month freedom from clinically driven TLR, 81.6% AFS, 92.9% limb salvage and 84.6% wound healing rate. |
SCB in AVF | |
Prospective, single-center study of 40 failing AVF treated with Selution SLR™ (Med Alliance), demonstrating 95.1% and 71.8% primary patency at 3- and 6-month, 100% technical and procedural success. | |
MATLIDA (Tang et al. 2020b) | Prospective, single-center study of MagicTouch™ for treatment of 33 failing AVF, demonstrating 97.9% and 82.9% primary patencies at 3 and 6 months, 100% technical and procedural success. |
AVG (Tan et al. 2021a) | Prospective, single-center study of MagicTouch™ for treatment of AVG at the graft-vein junction in 20 patients, finding 3- and 6-month primary patency rates of 76% and 65%. |
Future studies | |
LIFE-BTK (LIFE-BTK 2020) | Prospective, randomised controlled trial comparing Espirit™ BTK device (Abbott, Chicago, Illinois) for treatment of infra-popliteal disease compared to standard PTA device. |
MDK-1901 (MDK-1901 2022) | Prospective, randomised controlled trial comparing Selution SLR™ for treatment of superficial femoral and popliteal artery lesions in PAD patients. |
IMPRESSION (Sirolimus 2022) | Prospective, randomised controlled trial comparing MagicTouch™ balloon with standard POBA in the treatment of failing AVF on the rate of primary patency at 6 months. |
SAVE (SAVE Trial 2022) | Prospective, randomised controlled trial comparing Selution SLR™ balloon with standard POBA in the treatment of failing AVF, assessing the primary patency at 6 months as well as freedom from serious adverse events at 30 days. |
ACELEPIOS (Taneva et al. 2022) | Prospective, randomised controlled, single-center, noninferiority study comparing use of PCB (Ranger, Boston Scientific) with SCB (MagicTouch™) for treatment of femoropopliteal lesions. |
SIRONA (Teichgräber et al. 2021) | Prospective, randomised controlled, single-blinded, multi-center noninferiority study comparing use of PCB (commercially available) with SCB (MagicTouch™) for treatment of femoropopliteal lesions. |