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

NCT07270575 | Not Yet Recruiting

• 1 other identifier: RESCUE
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of lesions free from Clinically-Driven Target Lesion Revascularization (CD-TLR)

  Defined as freedom from any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.

  12 months

Secondary Outcomes (13)

• CD-TLR-free survival per target lesion

  Until the end of the follow-up period of 3 years

• Clinical response using Rutherford classification categories

  12, 24, and 36 months

• Wound status

  12, 24, and 36 months

• Freedom from major amputation of the target limb

  12 and 24 months

• Amputation-free survival

  Until the end of the follow-up period of 3 years

Study Arms (1)

Adult CLTI patients with infrapopliteal calcified lesions

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

Device: Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott

Interventions

Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott 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.

Also known as: Drug-eluting resorbable scaffold

Adult CLTI patients with infrapopliteal calcified lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult CLTI patients treated with the Esprit BTK everolimus-eluting resorbable scaffold following adequate vessel preparation for infrapopliteal artery disease.

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;
• Patients planned to receive an above ankle amputation of the target limb;
• Patients enrolled in ORACLE (ClinicalTrials.gov ID NCT07270562).

Sponsors & Collaborators

• Abbott: collaborator
• Cardiovascular and Interventional Radiological Society of Europe: lead

Related Publications (1)

• 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.

  PMID: 28584945 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Gerd Grözinger, Prof. Dr. med.

  SLK Kliniken Heilbronn GmbH

  STUDY CHAIR

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

  Medizinische Universität Graz

  STUDY CHAIR

• Raghu Lakshminarayan, Dr

  Hull University Teaching Hospital

  STUDY CHAIR

• Stefan Müller-Hülsbeck, Prof. Dr. med.

  DIAKO Krankenhaus gGmBH

  STUDY CHAIR

Central Study Contacts

Claire Poulet, PhD

CONTACT

+41 79 385 16 78; oracue@cirse.org

Dhwani S. Korde, PhD

CONTACT

+4367762942469; oracue@cirse.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 8, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share