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New trial will assess drug micro-infusion plus angioplasty in patients with CLI
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Researchers have launched a new study combining localized drug delivery with angioplasty in participants with critical limb ischemia.
Mercator MedSystems recently announced that patient enrollment is underway in the LIMBO-PTA trial. The randomized controlled trial is designed to evaluate use of localized drug delivery using the Bullfrog Micro-Infusion Device of dexamethasone with angioplasty. The first patient was treated at the University Heart Center in Bad Krozingen, Germany. Up to 120 patients will be enrolled, according to a company press release.
“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 [CLI]. We aim to show with this trial that the therapy can improve the outcomes in this desperate condition,” principal investigator Dierk Scheinert, MD, head of the department of interventional angiology, University Hospital of Leipzig, Germany, stated in the release.
Mercator MedSystems has also planned the LIMBO-ATX study, which combines localized drug delivery using the Bullfrog Micro-Infusion Device plus atherectomy in patients with CLI. This trial will be conducted in the United States and has been submitted to the FDA, according to the release.
The Bullfrog Micro-Infusion Device is designed to directly and nonsystemically inject therapeutic agents through blood vessel walls into adventitial tissues. The device features a balloon-sheathed microneedle that can be used with 0.014-in guidewires and 5F to 7F introducer sheaths. The device has received 510(k) clearance from the FDA and is also CE Marked, according to information on the company website.
Disclosure: Scheinert is principal investigator of the LIMBO-PTA trial.