Dissolving everolimus-releasing scaffold for blocked lower leg arteries in chronic limb-threatening ischemia
Follows 400 people with chronic limb-threatening ischemia treated with the Esprit BTK scaffold.
Key facts
- Who runs it
- Cardiovascular and Interventional Radiological Society of Europe
- Where
- Hull, United KingdomSee the site
- Trial code
- Registry title
- REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- 31 Aug 2026
- Expected to end
- Dec 2032
- Type of study
- Observational
- Treatments tested
- Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
- Record updated
- 23 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic limb-threatening ischemia, meaning very poor blood flow to the leg. They must have calcified (hardened) arteries below the knee that will be treated with the Esprit BTK scaffold.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Rutherford category 4 or higher (severe poor blood flow causing rest pain, wounds or tissue loss). The narrowed arteries below the knee must be calcified, as seen on fluoroscopy or CT-angiography.
- Earlier treatment
- People cannot join if they had a procedure inside the blood vessel at the treatment site within 4 weeks before the study procedure.
Main reasons for not taking part
- Minors, pregnant or breastfeeding women, and people who cannot freely give consent
- Poor blood flow into the leg (>30% narrowing) after treatment to improve it
- Fewer than 1 open artery carrying blood down to the foot
- Planned amputation of the treated leg above the ankle
- Taking part in the ORACLE study (NCT07270562)
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Rutherford classification category ≥4
- Treatment of infrapopliteal lesions with the Esprit BTK everolimus eluting resorbable scaffold system following adequate vessel preparation
- Calcification of target lesions must be visible on fluoroscopy or CT-angiography
- Patients competent and willing to provide informed consent
Who cannot take part
- Endovascular procedure(s) on the treatment site within 4 weeks before index procedure
- Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.)
- Inadequate inflow (>30% stenosis) following optimization
- Insufficient direct outflow (less than 1 run-off vessel)
- Patients planned to receive an above ankle amputation of the target limb
- Patients enrolled in ORACLE (ClinicalTrials.gov ID NCT07270562)
Where in United Kingdom
- Hull University Teaching Hospitals NHS TrustHull, United KingdomContact: Raghu Lakshminarayan, Dr (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Adult CLTI patients with infrapopliteal calcified lesions
Adult CLTI patients planned to receive the Esprit BTK™ resorbable scaffold following pre-dilatation with angioplasty balloon.
Treatment: Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
- Plain-language title
- Dissolving everolimus-releasing scaffold for blocked lower leg arteries in chronic limb-threatening ischemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 23 September 2026