Sirolimus-Eluting Scaffold for Critical Limb Ischemia
(ELITE-BTK Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on antiplatelet medications, you should not have any planned surgery or procedure that requires stopping these medications within 6 months after the procedure.
What data supports the effectiveness of the treatment MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold for Critical Limb Ischemia?
Research on similar treatments, like the Absorb bioresorbable vascular scaffold, shows promising results for treating limb-threatening ischemia, with high rates of keeping arteries open and low rates of major amputation over 24 months. This suggests that the MAGNITUDE scaffold, which uses a similar approach, may also be effective.12345
Is the Sirolimus-Eluting Scaffold generally safe for humans?
The safety of the Sirolimus-Eluting Scaffold, also known as the MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold, has been studied in animals, showing promising healing responses. However, similar bioresorbable scaffolds have been associated with a higher risk of blood clots compared to metallic stents in some studies.12567
What makes the MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold treatment unique for critical limb ischemia?
Research Team
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
Eligibility Criteria
This trial is for adults with Critical Limb Ischemia, specifically Rutherford categories 4 or 5. Participants must have specific narrowed leg vessels treatable with the MAGNITUDE BRS System and agree to follow-up visits. Exclusions include pregnancy, life expectancy <1 year, recent major cardiovascular events, severe kidney disease, uncontrolled diabetes (HbA1c > 10%), and certain other medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the MAGNITUDE BRS device or a PTA device for the treatment of narrowed infrapopliteal lesions
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of Major Adverse Limb Events and limb salvage
Treatment Details
Interventions
- MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold
Find a Clinic Near You
Who Is Running the Clinical Trial?
R3 Vascular Inc.
Lead Sponsor