By Donna Loyle, communications manager, LIMR
The LIFE-BTK randomized clinical trial, approved for Bryn Mawr Hospital, is evaluating the ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold system for planned treatment of narrowed arterial infrapopliteal lesions causing critical limb ischemia to improve luminal diameter.
The primary outcomes being measured include composite limb salvage and primary patency, and freedom from major adverse events and perioperative death.
Eligible participants are those with symptomatic critical limb ischemia, Rutherford category 4 or 5, requiring treatment of up to two de novo or restenotic infrapopliteal lesions, and vessel diameter of >2.5mm to <3.75mm, and total lesion length up to 100 mm.
Eligible participants are randomized into two study groups. One receives the ESPRIT BTK system; the other receives percutaneous transluminal angioplasty.
The MLH principal investigator is Antonis Pratsos, MD. For more, visit www.mainlinehealth.org/research/clinical-trials/life-btk