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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Limb Threatening Ischemia; Chronic Limb-Threatening Ischemia
• Intervention / Treatment: Device: Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Claire Poulet, PhD; Phone Number: +41 79 385 16 78; Email: oracue@cirse.org
• Study Contact Backup: Name: Dhwani S. Korde, PhD; Phone Number: +4367762942469; Email: oracue@cirse.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: Drug-eluting resorbable scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD-TLR-free survival per target lesion	Defined as the time between first index procedure and any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.	Until the end of the follow-up period of 3 years
Clinical response using Rutherford classification categories	The Rutherford classification is a clinical scale used to categorize the severity of peripheral arterial disease: Category 0 = asymptomatic; Category 1 = mild claudication; Category 2 = moderate claudication; Category 3 = severe claudication; Category 4 = ischemic rest pain; Category 5 = minor tissue loss; Category 6 = severe tissue loss.	12, 24, and 36 months
Amputation-free survival	Defined as time between first index procedure and amputation of the target limb, minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the index procedure).	Until the end of the follow-up period of 3 years
Overall survival	Defined as the time between the first index procedure and death of any cause.	Until the end of the follow-up period of 3 years
Patient-reported health-related quality-of-life	Measured by Vascular Quality of Life Questionnaire - 6 items (VascuQol-6), which is a short patient-reported outcome measure (PROM), used to assess health-related quality of life in people with PAD. It consists of 6 questions, each scored from 1 to 7, with 1 as the worst possible quality of life and 7 as the best possible quality of life. Higher overall scores reflect better quality of life for patients with PAD.	Baseline, Day 0 (day of procedure), 6-, 12-, 24-, 26-months post treatment
Frequency of major adverse limb events (MALE) and peri-operative death (POD).	MALE include above-ankle amputation in the index limb, major re-intervention on the index limb at 6 months and POD includes perioperative (30-day) mortality.	6 months for MALE; Within 30 days after the index procedure for POD
Clinical response using ankle-brachial index (ABI)	The ankle-brachial index (ABI) is a non-invasive measure calculated as the ratio of systolic blood pressure at the ankle to systolic blood pressure at the arm. ABI categories commonly used to classify peripheral arterial disease are: >1.40 = non-compressible arteries; 1.00-1.40 = normal; 0.91-0.99 = borderline; 0.41-0.90 = mild to moderate peripheral arterial disease; <0.40 = severe peripheral arterial disease.	12, 24, and 36 months
Clinical response using toe pressure	The toe pressure test measures distal limb perfusion by recording systolic pressure at the toe. In CLTI patients, toe pressure ≤30 mmHg is commonly used to indicate severe ischemia, while values >30 mmHg suggest better perfusion.	12, 24, and 36 months
Clinical response using WIfi (wound, ischemia and foot infection) score	The WIfI classification is a staging system used to assess CLTI based on wound extent, ischemia severity, and foot infection. Each component is graded from 0 (none) to 3 (severe). Lower WIfI scores indicate a lower risk of limb loss and a lesser urgency for revascularization, whereas higher scores indicate greater disease severity, higher amputation risk, and greater potential benefit from revascularization.	12, 24, and 36 months
Wound status	Defined as healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening).	12, 24, and 36 months
Freedom from major amputation of the target limb	Defined as absence of any amputation of the target limb (above ankle).	12 and 24 months
Frequency and severity of procedural complications and other adverse events	Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe.	Within 30 days after the index procedure
Restoration of normal lumen per target lesion	Defined as residual stenosis ≤30%, immediately after completion of full planned procedure.	Immediately upon procedure completion

Collaborators and Investigators

• Sponsor: Cardiovascular and Interventional Radiological Society of Europe
• Collaborators: Abbott
• Investigators: Study Chair: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Peripheral artery disease; CLTI; Infrapopliteal arteries; Critical Limb-Threatening Ischemia; Infrapopliteal 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
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease
• Other Study ID Numbers: RESCUE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No