PMID- 35906491
OWN - NLM
STAT- MEDLINE
DCOM- 20221104
LR  - 20221104
IS  - 1432-086X (Electronic)
IS  - 0174-1551 (Print)
IS  - 0174-1551 (Linking)
VI  - 45
IP  - 11
DP  - 2022 Nov
TI  - Sirolimus-Coated Balloon Angioplasty of Infra-popliteal Lesions for the Treatment 
      of Chronic Limb-Threatening Ischemia: Study Protocol for the Randomized 
      Controlled LIMES Study.
PG  - 1716-1724
LID - 10.1007/s00270-022-03213-z [doi]
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Teichgraber, Ulf
AU  - Teichgraber U
AUID- ORCID: 0000-0002-4048-3938
AD  - Department of Radiology, Jena University Hospital, Friedrich-Schiller-University 
      Jena, Am Klinikum 1, 07747, Jena, Germany. ulf.teichgraeber@med.uni-jena.de.
FAU - Platzer, Stephanie
AU  - Platzer S
AD  - Center for Clinical Studies, Jena University Hospital, 
      Friedrich-Schiller-University Jena, Jena, Germany.
FAU - Lehmann, Thomas
AU  - Lehmann T
AD  - Center for Clinical Studies, Jena University Hospital, 
      Friedrich-Schiller-University Jena, Jena, Germany.
FAU - Ingwersen, Maja
AU  - Ingwersen M
AD  - Department of Radiology, Jena University Hospital, Friedrich-Schiller-University 
      Jena, Am Klinikum 1, 07747, Jena, Germany.
FAU - Aschenbach, Rene
AU  - Aschenbach R
AD  - Department of Radiology, Jena University Hospital, Friedrich-Schiller-University 
      Jena, Am Klinikum 1, 07747, Jena, Germany.
FAU - Beschorner, Ulrich
AU  - Beschorner U
AD  - Department of Angiology, University Heart Center Freiburg-Bad Krozingen, Bad 
      Krozingen, Germany.
FAU - Scheinert, Dierk
AU  - Scheinert D
AD  - Department of Angiology, University Hospital Leipzig, Leipzig, Germany.
FAU - Zeller, Thomas
AU  - Zeller T
AD  - Department of Angiology, University Heart Center Freiburg-Bad Krozingen, Bad 
      Krozingen, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT04772300
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20220729
PL  - United States
TA  - Cardiovasc Intervent Radiol
JT  - Cardiovascular and interventional radiology
JID - 8003538
RN  - 0 (Coated Materials, Biocompatible)
RN  - P88XT4IS4D (Paclitaxel)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
MH  - Humans
MH  - *Angioplasty, Balloon/methods
MH  - Chronic Limb-Threatening Ischemia
MH  - *Citrus aurantiifolia
MH  - Coated Materials, Biocompatible
MH  - Femoral Artery
MH  - Paclitaxel/adverse effects
MH  - *Peripheral Arterial Disease/therapy
MH  - Popliteal Artery
MH  - Sirolimus
MH  - Treatment Outcome
MH  - Vascular Patency
PMC - PMC9626410
OTO - NOTNLM
OT  - Balloon angioplasty
OT  - Peripheral artery disease
OT  - Sirolimus
COIS- All authors declare that they have no conflict of interest with respect to this 
      article.
EDAT- 2022/07/30 06:00
MHDA- 2022/11/04 06:00
PMCR- 2022/07/29
CRDT- 2022/07/29 23:37
PHST- 2022/03/02 00:00 [received]
PHST- 2022/06/23 00:00 [accepted]
PHST- 2022/07/30 06:00 [pubmed]
PHST- 2022/11/04 06:00 [medline]
PHST- 2022/07/29 23:37 [entrez]
PHST- 2022/07/29 00:00 [pmc-release]
AID - 10.1007/s00270-022-03213-z [pii]
AID - 3213 [pii]
AID - 10.1007/s00270-022-03213-z [doi]
PST - ppublish
SO  - Cardiovasc Intervent Radiol. 2022 Nov;45(11):1716-1724. doi: 
      10.1007/s00270-022-03213-z. Epub 2022 Jul 29.