Sirolimus-Coated Balloon Angioplasty of Infra-popliteal Lesions for the Treatment of Chronic Limb-Threatening Ischemia: Study Protocol for the Randomized Controlled LIMES Study.

Ulf K TeichgräberStephanie PlatzerThomas LehmannMaja IngwersenRené AschenbachUlrich BeschornerDierk ScheinertThomas Zeller

Published in: Cardiovascular and interventional radiology (2022)

If sirolimus-coated balloon angioplasty turns out to be superior to uncoated-balloon angioplasty regarding patency of infra-popliteal lesions without safety signals, it could become a welcome treatment option for patients with CLTI. Trial Registration ClinicalTrial.gov Identifier: NCT04772300, German Clinical Trials Register: DRKS00024629. Level of Evidence Level 2a, randomized controlled trial.

Keyphrases

clinical trial
phase iii
open label
double blind
randomized controlled trial
study protocol
drug induced