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 Teichgräber, Stephanie Platzer, Thomas Lehmann, Maja Ingwersen, René Aschenbach, Ulrich Beschorner, Dierk Scheinert, Thomas Zeller, Ulf Teichgräber, Stephanie Platzer, Thomas Lehmann, Maja Ingwersen, René Aschenbach, Ulrich Beschorner, Dierk Scheinert, Thomas Zeller

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.

Keywords: Balloon angioplasty; Peripheral artery disease; Sirolimus.

Conflict of interest statement

All authors declare that they have no conflict of interest with respect to this article.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow chart. *Pre-dilation, drug-coated balloon dilation, standard balloon dilation, and post-dilation should last for at least 60 s each. Dilation for 180 s each is strongly recommended. DCB drug-coated balloon, ITT intention to treat

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