LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS treatment-Below The Knee) Randomized Controlled Trial
Study of ESPRIT BTK System for Treatment of Critical Limb Ischemia
Sponsor: Abbott Medical Devices
Enrolling: Male and Female Patients
IRB Number: AAAS9053
U.S. Govt. ID: NCT04227899
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: The objective of the LIFE-BTK RCT is to evaluate the safety and efficacy of the ESPRIT BTK device (which is a bioresorbable polymeric scaffold with the everolimus drug and a bioresorbable polymeric coating mounted on a balloon dilatation catheter) compared to Percutaneous Transluminal Angioplasty (PTA), which is is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow can be restored. The balloon is then deflated and the catheter is removed. This will be looked at in patients with arterial narrowing in infrapopliteal lesions causing CLI (Critical Limb Ischemia).
Investigator
Sahil Parikh, MD
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366