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

NCT ID: NCT07270575

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2032-12-31

Brief 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

Keywords

CLTI; Critical Limb-Threatening Ischemia; Infrapopliteal artery disease; Peripheral artery disease; Esprit BTK Everolimus Eluting Resorbable Scaffold; Drug-eluting resorbable scaffold; Resorbable vascular scaffold; Real-world evidence study; Patients with infrapopliteal disease; Calcified peripheral artery lesions; Infrapopliteal arteries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult CLTI patients with infrapopliteal calcified lesions

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

Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Drug-eluting resorbable scaffold

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Cardiovascular and Interventional Radiological Society of Europe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerd Grözinger, Prof. Dr. med.

Role: STUDY_CHAIR

SLK Kliniken Heilbronn GmbH

Marianne Brodmann, Univ.-Prof. Dr. med.

Role: STUDY_CHAIR

Medizinische Universität Graz

Raghu Lakshminarayan, Dr

Role: STUDY_CHAIR

Hull University Teaching Hospital

Stefan Müller-Hülsbeck, Prof. Dr. med.

Role: STUDY_CHAIR

DIAKO Krankenhaus gGmBH

Central Contacts

Claire Poulet, PhD

Role: CONTACT

Phone: +41 79 385 16 78

Email: oracue@cirse.org

Dhwani S. Korde, PhD

Role: CONTACT

Phone: +4367762942469

Email: oracue@cirse.org

References

Filippiadis DK, Binkert C, Pellerin O, Hoffmann RT, Krajina A, Pereira PL. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1141-1146. doi: 10.1007/s00270-017-1703-4. Epub 2017 Jun 5.

Reference Type: BACKGROUND

PMID: 28584945 (View on PubMed)

Other Identifiers

RESCUE

Identifier Type: -

Identifier Source: org_study_id