4 Clinical Trials for Various Conditions
A prospective, single-arm, multi-center Coronary IVL IDE Study with 47 US sites
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.
The purpose of this registry study is to gather real world standard of care (SOC) data on the safety and performance on the Roxwood Medical catheter devices in the treatment of stenotic lesions and CTO.