LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS treatment-Below The Knee) Randomized Controlled Trial
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 |
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).
This study is closed
Investigator
Sahil Parikh, MD
Are you 18 years of age or older? |
Yes |
No |