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REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia

Study acronym: RESCUE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 13 entries
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv4
  3. Start date: Apr 2026 to Aug 2026
    • Primary completion pushed from Apr 2032 to Aug 2032
    v3
  4. Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 16 to 13
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings. The study focuses on people who have heavily calcified arteries in the infrapopliteal areas of the leg. These drug-eluting resorbable scaffolds release a medication that helps prevent the inner wall of the blood vessel from thickening after injury or surgery. This can reduce the chance of the artery becoming blocked again (a problem called restenosis), while also giving temporary structural support to the vessel. Over time, the scaffold naturally dissolves in the body, which may lower the long-term risks associated with permanent metal stents.
Trial Details
NCT Number NCT07270575
Lead Sponsor Cardiovascular and Interventional Radiological Society of Europe
Collaborators: Abbott
Conditions
(from sponsor)		 Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
Related terms Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov