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

Cardiovascular and Interventional Radiological Society of Europe

Status: Begins enrollment in 1 month

Conditions: Chronic Limb Threatening Ischemia; Chronic Limb-Threatening Ischemia

Treatments: Device: Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07270575

RESCUE

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Rutherford classification category ≥4;
2. Treatment of infrapopliteal lesions with the Esprit BTK everolimus eluting resorbable scaffold system following adequate vessel preparation;
3. Calcification of target lesions must be visible on fluoroscopy or CT-angiography;
4. Patients competent and willing to provide informed consent.

Exclusion criteria

1. 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.);
2. Inadequate inflow (>30% stenosis) following optimization;
3. Insufficient direct outflow (less than 1 run-off vessel);
4. Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;
5. Patients planned to receive an above ankle amputation of the target limb;
6. Patients enrolled in ORACLE (ClinicalTrials.gov ID NCT07270562).

Trial design

400 participants in 1 patient group

Adult CLTI patients with infrapopliteal calcified lesions

Description:

Adult CLTI patients planned to receive the Esprit BTK™ resorbable scaffold following pre-dilatation with angioplasty balloon.

Treatment:

Device: Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott