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NCT Number: NCT07270575

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Other names: Drug-eluting resorbable scaffold

Primary outcomes

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

    Time frame: 12 months

    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.

Secondary outcomes

  1. CD-TLR-free survival per target lesion

    Time frame: Until the end of the follow-up period of 3 years

    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.

  2. Clinical response using Rutherford classification categories

    Time frame: 12, 24, and 36 months

    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.

  3. Wound status

    Time frame: 12, 24, and 36 months

    Defined as healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening).

  4. Freedom from major amputation of the target limb

    Time frame: 12 and 24 months

    Defined as absence of any amputation of the target limb (above ankle).

  5. Amputation-free survival

    Time frame: Until the end of the follow-up period of 3 years

    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).

  6. Overall survival

    Time frame: Until the end of the follow-up period of 3 years

    Defined as the time between the first index procedure and death of any cause.

  7. Patient-reported health-related quality-of-life

    Time frame: Baseline, Day 0 (day of procedure), 6-, 12-, 24-, 26-months post treatment

    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.

  8. Frequency and severity of procedural complications and other adverse events

    Time frame: Within 30 days after the index procedure

    Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe.

  9. Frequency of major adverse limb events (MALE) and peri-operative death (POD).

    Time frame: 6 months for MALE; Within 30 days after the index procedure for 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.

  10. Clinical response using ankle-brachial index (ABI)

    Time frame: 12, 24, and 36 months

    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.

  11. Clinical response using toe pressure

    Time frame: 12, 24, and 36 months

    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. Clinical response using WIfi (wound, ischemia and foot infection) score

    Time frame: 12, 24, and 36 months

    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.

  13. Restoration of normal lumen per target lesion

    Time frame: Immediately upon procedure completion

    Defined as residual stenosis ≤30%, immediately after completion of full planned procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Poulet, PhD

CONTACT

[email protected]

+41 79 385 16 78

Dhwani S. Korde, PhD

CONTACT

[email protected]

+4367762942469

Sponsors and collaborators

Lead sponsor

Cardiovascular and Interventional Radiological Society of Europe

Other

Collaborators

  • Abbott

Registry information

Acronym: RESCUE

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Dec 8, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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