The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
-
CUMC/NYP, New York, New York, United States, 10032
NYU Langone Health, New York, New York, United States, 30253
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
R3 Vascular Inc.,
Eric Secemsky, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center
Marianne Brodmann, MD, PRINCIPAL_INVESTIGATOR, Medical University of Graz
Ramon L Varcoe, MD, PRINCIPAL_INVESTIGATOR, Prince of Wales Private Hospital
2032-03-01