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

NCT07270575 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-12-30

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Limb Threatening Ischemia
  • Chronic Limb-Threatening Ischemia

Interventions

DEVICE

Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott

The Esprit BTK™ is a bioresorbable vascular scaffold designed for arteries below the knee. It provides temporary support to keep the vessel open while releasing everolimus-an antiproliferative drug that helps prevent excessive tissue growth and reduces the risk of restenosis. As the scaffold delivers the medication, it gradually dissolves, potentially lowering long-term risks associated with permanent stents.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Cardiovascular and Interventional Radiological Society of Europe

    lead OTHER

Principal Investigators

  • Gerd Grözinger, Prof. Dr. med. · SLK Kliniken Heilbronn GmbH

  • Marianne Brodmann, Univ.-Prof. Dr. med. · Medizinische Universität Graz

  • Raghu Lakshminarayan, Dr · Hull University Teaching Hospital

  • Stefan Müller-Hülsbeck, Prof. Dr. med. · DIAKO Krankenhaus gGmBH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2032-04-30
Completion
2032-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07270575 on ClinicalTrials.gov