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Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

Study acronym: LIMES
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 26, 2025 (before its estimated April 17, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 2027 to Apr 17, 2026v10 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 23 to 19
    • Study completion date: Sep 2028 to Nov 17, 2028
    • Collaborators: 3 to 4
    • Eligibility criteria expanded, about 4 words
  2. Primary completion date: Dec 2026 to Dec 2027
    • Study sites: 25 to 23
    • Study completion date: Jul 2027 to Sep 2028
    v9
  3. Study sites: 23 to 25
    • Collaborators revised (3)
    • Publications: details revised at 1 of 1 entry
    v8
  4. Study sites: 21 to 23
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints revised (31)
    • Study description expanded, about 3 words
    v7
  5. Study sites: 19 to 21
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 32 to 31
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 20 to 19
    • Start date changed from estimate of Jan 2022 to Feb 10, 2022
    v5
  2. Primary completion date: May 2026 to Dec 2026v4 Show 6 more changesShow less
    • Start date: Nov 2021 to Jan 2022
    • Study sites: 19 to 20
    • Study completion date: Dec 2026 to Jul 2027
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: 30 to 32
    • Collaborators: 4 to 3
  3. Start date: Jun 2021 to Nov 2021v3
  4. Study sites: 4 to 19
    • Secondary endpoints: details revised at 1 of 30 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a prospective, interventional, multicenter 1:1 randomized trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease.
Trial Details
NCT Number NCT04772300
Lead Sponsor Jena University Hospital
Collaborators: Concept Medical Inc., Vascuscience, CoreLab Black Forest, Center for Clinical Studies Jena
Conditions
(from sponsor)		 Peripheral Artery Disease
Related terms Peripheral Arterial Disease
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov