RESCUE
Research type
Research Study
Full title
Resorbable scaffolds with everolimus-elution for the treatment of infrapopliteal artery disease in patients with chronic limb-threatening ischemia
IRAS ID
372630
Contact name
Raghuram Lakshminarayan
Contact email
Sponsor organisation
Cardiovascular and Interventional Radiological Society of Europe (CIRSE)
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 4 months, 31 days
Research summary
Chronic limb-threatening ischaemia (CLTI) is an advanced form of poor blood circulation in the legs which can lead to severe pain, wounds that do not heal, and amputation. Many patients with CLTI have narrowed or blocked arteries below the knee, which can be difficult to treat. Re-narrowing after treatment is common and often leads to the need for further interventions.
The Esprit BTK everolimus-eluting resorbable scaffold is a temporary device used to treat arterial disease below the knee by helping keep the artery open while releasing everolimus, a medicine intended to reduce the chance of re-narrowing. Over time, the scaffold resorbs, avoiding the long-term presence of a permanent metal implant. Although several studies have reported promising results, available evidence remains limited to controlled trial settings with highly selected patient populations.
RESCUE is a prospective observational study designed to generate evidence on the use of the Esprit BTK scaffold in real-life clinical practice. The primary objective is to evaluate how effectively the treatment prevents patients from needing further intervention in the same area. A key secondary objective is to assess how well it helps prevent major amputations. The study will also evaluate wound healing, safety, survival, and patient quality of life.
RESCUE follows routine clinical care and does not require any additional study-specific hospital visits or burdensome procedures. Study data will be collected from medical records and from a voluntary patient questionnaire on health-related quality of life. Follow-up information may be collected by telephone if no routine hospital visit is planned at the relevant time point. Up to 400 patients across multiple centres in Europe will be included.
Overall, RESCUE aims to improve our understanding of the role of everolimus-eluting resorbable scaffolds in the management of patients with CLTI and may help inform future treatment strategies for this high-risk population.
REC name
London - Westminster Research Ethics Committee
REC reference
26/PR/0664
Date of REC Opinion
18 Jun 2026
REC opinion
Further Information Favourable Opinion