RESCUE

REsorbable SCaffolds with everolimUs-Elution for the treatment of infrapopliteal artery disease in CLTI patients

Status: in design

Study summary | Objective and outcome measures | Steering Committee

Study summary

RESCUE is a Europe-wide, prospective, observational cohort study designed to evaluate the effectiveness of the Esprit BTK Everolimus Eluting Resorbable Scaffolds in 400 participants with critical limb-threatening ischemia (CLTI). The study aims to generate real-world data on the use of this new treatment modality in infrapopliteal artery disease.

Drug-eluting resorbable scaffolds deliver antiproliferative agents directly to a vessel wall with the aim to prevent thickening of the inner vessel wall occurring either due to injury or surgery, and reduce restenosis whilst providing temporary structural support. Over time, these scaffolds are naturally resorbed by the body, minimising long-term risks arising from the use of permanent stents.

RESCUE plans to recruit a maximum of 400 patients during the 3-year enrolment phase with an anticipated start in April 2026. Follow-up will continue for 1 year beyond the enrolment phase.

The project is funded by Abbott via their Investigator Sponsored Studies Program.

Objectives and outcome measures

The primary objective of RESCUE is to assess, at 12 months, the effectiveness of Esprit BTK scaffolds in preventing the need for clinically driven target lesion revascularization (CD-TLR).

As secondary objectives, RESCUE intends to examine the effectiveness of the device in i) preventing binary restenosis and restoring long-term patency of the vessel, ii) improving clinical symptoms such as limb ischemia, iii) promoting wound healing and preventing amputation, and iv) prolonging survival.

The study will additionally evaluate the device safety, as well as its impact on health-related quality of life.

Steering Committee