Mercator MedSystems, has announced its first patient enrolment in the company's Below the Knee (BTK) LIMBO-PTA clinical trial
This trial uses the company's Bullfrog Micro-Infusion device to locally deliver an anti-inflammatory steroid (dexamethasone) in angioplasty procedures.
The study will measure the benefit of adding an anti-inflammatory to the catheter-based re-opening of arteries below the knee in patients suffering from critical limb ischemia (CLI).
In vessels below the knee, while balloon angioplasty is able to open the clogged artery, a scarring process usually leads to re-obstruction of the vessel within six months of the procedure.
The purpose of locally delivering an anti-inflammatory drug to the vessel is to extinguish the biological signals that cause the buildup of scar tissue and lead to restenosis, according to Mercator.
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.
In angioplasty procedures, a high-pressure balloon is used to compress plaque and force the artery open, while atherectomy uses catheters with cutting blades or rough spinning surfaces to physically remove plaque from the artery.
Mercator said that both of these procedures are well known to cause blood vessel inflammation that leads to the re-occlusive scarring process.
Elias Noory, at the University Heart Center in Bad Krozingen, Germany, treated the first patient in the LIMBO-PTA trial, with up to 120 patients intended to be enrolled over the coming months.
Dierk Scheinert, head department of interventional angiology, University Hospital of Leipzig and the principal investigator of the trial, said: "There remains a real need for enhancements in therapy for treating patients with critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desperate condition."