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Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease — ELITE-BTK  

Chronic Limb-Threatening Ischemia Clinical Trial

Official title:
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

Clinical Trial Summary

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 300 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at approximately 50 clinical sites internationally.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Chronic Limb-Threatening Ischemia
  • Ischemia
Clinical Trial Details
NCT number NCT06071429
Study type Interventional
Source R3 Vascular Inc.
Contact Kristine Orosz
Phone 1 (408) 420-7446
Email korosz@r3vascular.com
Status Not yet recruiting
Phase N/A
Start date January 1, 2025
Completion date March 1, 2032
View Details
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