Patient enrolment has begun in Bad Krozingen, Germany, for Mercator MedSystem’s LIMBO-PTA clinical trial. This study measures the benefits of adding drug delivery to the catheter-based re-opening of the arteries below the knee in patients suffering from critical limb ischaemia (CLI). The trial combines localised drug delivery using the Mercator MedSystem Bullfrog micro-infusion device and dexamethasone with angioplasty.
Two CLI trials are planned by Mercator, both of which are randomised, controlled trials: the German study (LIMBO-PTA), which pairs the therapy with angioplasty, and a United States study (LIMBO-ATX) which combines the therapy with atherectomy and has been submitted to the US Food and Drug Administration.
The first patient in the LIMBO-PTA trial was treated by Elias Noory at the University Heart Center in Bad Krozingen, Germany. A total of up to 120 patients are intended to be enrolled over the coming months. Dierk Scheinert, head of the Department of Interventional Angiology, University Hospital of Leipzig and the principal investigator of the trial, comments, “We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with critical limb ischaemia. We aim to show with this trial that the therapy can improve the outcomes in this desperate condition.”
Trent Reutiman, the chief executive officer of Mercator, notes, “There is an unmet need in delivering a reliable drug therapy to keep arteries open below the knee. Our results in above-knee arteries from our DANCE-Pilot study and our most recent experience from our larger, 285 patient DANCE trial provide us with confidence that our micro-infusion technology can place drug directly where it is needed and will have a strong benefit.”