Mercator MedSystems has announced completion of enrolment in the company’s LIMBO-ATX (Lower-limb adventitial infusion of dexamethasone via Bullfrog to reduce occurrence of restenosis after atherectomy-based revascularisation) clinical trial. The primary six-month endpoint data is expected to be available in the second quarter of 2018
LIMBO-ATX is a prospective, multicentre, randomised controlled trial that enrolled over 100 patients with arterial obstructions in arteries below the knee. The trial was designed to use Mercator’s proprietary Bullfrog microinfusion catheter to test a new treatment strategy to potentially improve blood flow and decrease repeat revascularisation procedures in below-the-knee critical limb ischaemia. Current solutions for critical limb ischaemia face many limitations, leaving a significant unmet need for these patients and physicians treating the disease.
“The investigators associated with LIMBO-ATX are very excited to have completed enrolment in this important study. Meaningful results utilising Mercator’s proprietary delivery technique could lead to a change in the standard of care treatment of critical limb ischaemia in the USA,” said George Adams, national co-principal investigator for LIMBO-ATX and director of Cardiovascular and Peripheral Vascular Research at the University of North Carolina, Chapel Hill.
Mercator previously sponsored the DANCE trial, which reached its primary endpoint in early 2017 and demonstrated positive patency outcomes from delivering dexamethasone in combination with angioplasty or atherectomy in above-the-knee endovascular revascularisation.