Mercator MedSystems, Inc. has announced enrollment of the first participants in the LIMBO-ATX trial, which will evaluate lower-limb adventitial infusion of dexamethasone using the Bullfrog Micro-Infusion device to reduce the occurrence of restenosis after atherectomy-based revascularization of lesions below-the-knee in symptomatic patients with critical limb ischemia.
The trial will utilize a first-in-class perivascular drug-delivery device paired with below-the-knee atherectomy. The trial design was approved by the FDA under an Investigational New Drug application, according to a company press release. George Adams, MD, from the University of North Carolina REX Hospital in Raleigh, North Carolina, and Donald Jacobs, MD, from Saint Louis University in Saint Louis Missouri, serve as co-principal investigators.
The first participants were enrolled at Adams’ institution and by Jason Yoho, MD, at the New Braunfels Cardiology Group at Guadalupe Regional Hospital in Seguin, Texas, according to the release.
The Bullfrog Micro-Infusion Device was designed for direct, non-systemic and safe injection of therapeutic agents through blood vessel walls into adventitial tissues. The device features a balloon-sheathed microneedle. It is compatible with 0.014-in guidewires and 5F to 7F introducer sheaths. The balloon is inflated to 2 atmospheres with radio-opaque contrast and saline at the injection site, according to information on the device website.
The study has two arms. In one arm, participants assigned dexamethasone delivery will receive a 4-mg/dL preparation of dexamethasone sodium phosphate injection following atherectomy-based endovascular revascularization. In the control arm, participants will receive standard endovascular revascularization consisting of atherectomy with or without angioplasty and with or without stent placement, with no additional drug therapy, according to the trial description on ClinicalTrials.gov.
The primary outcome measures are freedom from major adverse limb events within 6 months; freedom from clinically driven target lesion revascularization within 6 months; freedom from a composite of death within 30 days from index procedure, major adverse limb events, major unplanned amputation or clinically driven TLR within 6 months; and transverse-view vessel area loss percentage of the target lesion at 6 months by quantitative vascular angiography or prior to any clinically driven TLR of the target lesion before 6 months, according to ClinicalTrials.gov.
The study will enroll up to 120 participants at up to 30 sites in the United States and Europe.
“We are very excited to be one of the centers initiating enrollment of the LIMBO-ATX study. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia, and we hope to show that this therapy can improve patient outcomes and prevent amputation,” Adams stated in the release.
ClinicalTrials.gov. clinicaltrials.gov/ct2/show/NCT02479620?term=limbo-atx&rank=1. Accessed on July 27, 2016.
Mercator MedSystems, Inc. www.mercatormed.com/bullfrog-micro-infusion-device/.
Disclosure: Adams is co-principal investigator of the LIMBO-ATX trial (Mercator MedSystems, Inc.).