Sirolimus-coated balloon angioplasty of infra-popliteal lesions for the treatment of chronic limb-threatening ischemia: study protocol for the randomized controlled LIMES study

Abstract: Purpose
Evidence on efficacy and long-term safety of paclitaxel-coated devices is still conflicting. Therefore, this study aims to assess whether sirolimus-coated balloon angioplasty is safe and effective for the treatment of infra-popliteal occlusions in patients with chronic limb-threatening ischemia (CLTI).

Study design
The randomized controlled, single-blinded, multicentre, investigator-initiated study aims to enrol 230 participants with CLTI and infra-popliteal occlusions at up to 25 centres. Patients will be randomized in a 1:1 ratio to either sirolimus-coated balloon angioplasty or to plain old balloon angioplasty (POBA). Bailout stenting in case of flow-limiting dissection or ≥ 50% residual diameter stenosis is permitted.

Outcome measures
Primary outcome is the Kaplan–Meier estimate of primary patency at 6 months, defined as the absence of target lesion occlusion with restoration of in-line flow to the ankle. Key secondary outcome is non-inferiority in the proportionate occurrence of major adverse limb events and perioperative all-cause death at 30 days. Overall, participants will be followed for 36 months to assess further secondary efficacy and safety outcomes.

Assumed gain of knowledge
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

Object Details

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch
• Notes: CardioVascular and interventional radiology. - 45, 11 (2022) , 1716-1724, ISSN: 1432-086X

Contributors, Places and Time

• Event: Veröffentlichung
• (where): Freiburg
• (who): Universität
• (when): 2022
• Creator: Teichgräber, Ulf ; Platzer, Stephanie ; Lehmann, Thomas ; Ingwersen, Maja ; Aschenbach, René ; Beschorner, Ulrich ; Scheinert, Dierk Wolfgang ; Zeller, Thomas

Further information

• DOI: 10.1007/s00270-022-03213-z
• URN: urn:nbn:de:bsz:25-freidok-2289021
• Rights: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Last update: 25.03.2025, 1:46 PM CET