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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Number of lesions free from Clinically-Driven Target Lesion Revascularization (CD-TLR) [Срок оценки: 12 months]

Вторичные конечные точки (12)

• CD-TLR-free survival per target lesion [Срок оценки: Until the end of the follow-up period of 3 years]
• Clinical response using Rutherford classification categories [Срок оценки: 12, 24, and 36 months]
• Wound status [Срок оценки: 12, 24, and 36 months]
• Freedom from major amputation of the target limb [Срок оценки: 12 and 24 months]
• Amputation-free survival [Срок оценки: Until the end of the follow-up period of 3 years]
• Overall survival [Срок оценки: Until the end of the follow-up period of 3 years]
• Patient-reported health-related quality-of-life [Срок оценки: Baseline, Day 0 (day of procedure), 6-, 12-, 24-, 26-months post treatment]
• Frequency and severity of procedural complications and other adverse events [Срок оценки: Within 30 days after the index procedure]
• Frequency of major adverse limb events (MALE) and peri-operative death (POD). [Срок оценки: 6 months for MALE; Within 30 days after the index procedure for POD]
• Clinical response using ankle-brachial index (ABI) [Срок оценки: 12, 24, and 36 months]
• Clinical response using toe pressure [Срок оценки: 12, 24, and 36 months]
• Clinical response using WIfi (wound, ischemia and foot infection) score [Срок оценки: 12, 24, and 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07270575 · RESCUE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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