ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia

Обзор

ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice. OA is a procedure that uses a tiny spinning tool to gently remove hard calcium from inside an artery, helping to open the vessel so other treatments-like balloons or stents-can work better. The study focuses on people who have heavily calcified arteries in the femoropopliteal or infrapopliteal areas of the leg.

Вмешательства

• Устройство Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
  The Stealth 360™ Peripheral Orbital Atherectomy System uses a diamond-coated, eccentrically mounted crown with bi-directional capabilities that treat a wide range of vessels, enabling single device treatment of multiple lesions and vessel sizes.

Первичные конечные точки

• Number of lesions with ≤30% residual stenosis after completion of full planned procedure [Срок оценки: Immediately after procedure completion]

Вторичные конечные точки (12)

• Number of lesions with ≤30% residual stenosis after any unplanned endovascular intervention(s) [Срок оценки: Immediately after procedure completion]
• Need for unplanned bailout stenting [Срок оценки: Immediately after procedure completion]
• Number of participants free from Clinically-Driven Target Lesion Revascularization (CD-TLR) [Срок оценки: 12 and 24 months]
• CD-TLR-free survival [Срок оценки: Until the end of the follow-up period of 2 years]
• Clinical response using Rutherford classification categories [Срок оценки: 12 and 24 months]
• Wound status [Срок оценки: 12 and 24 months]
• Freedom from 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 2 years]
• Overall survival [Срок оценки: Until the end of the follow-up period of 2 years]
• Patient-reported health-related quality-of-life [Срок оценки: Baseline, 6, 12 and 24 months post treatment]
• Frequency and severity of procedural complications and other adverse events [Срок оценки: Within 30 days after the OA procedure]
• Clinical response using ankle-brachial index (ABI) [Срок оценки: 12 and 24 months]

Критерии участия

Критерии включения

• Rutherford classification category ≥4;
• Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System;
• 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 RESCUE (ClinicalTrials.gov ID NCT07270575).

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

• Nordanstig J, Wann-Hansson C, Karlsson J, Lundstrom M, Pettersson M, Morgan MB. Vascular Quality of Life Questionnaire-6 facilitates health-related quality of life assessment in peripheral arterial disease. J Vasc Surg. 2014 Mar;59(3):700-7. doi: 10.1016/j.jvs.2013.08.099. Epub 2013 Dec 15. PMID 24342060
• 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: NCT07270562 · ORACLE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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