NCT07270562尚未招募不适用
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
Cardiovascular and Interventional Radiological Society of Europe0 个研究点目标入组 250 人开始时间: 2026年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- Number of lesions with ≤30% residual stenosis after completion of full planned procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Number of lesions with ≤30% residual stenosis after completion of full planned procedure
时间窗: Immediately after procedure completion
Defined as residual stenosis ≤30%, immediately after completion of full planned procedure (OA + any planned adjunctive intervention(s)).
次要结局
- Frequency and severity of procedural complications and other adverse events(Within 30 days after the OA procedure)
- Number of lesions with ≤30% residual stenosis after any unplanned endovascular intervention(s)(Immediately after procedure completion)
- Need for unplanned bailout stenting(Immediately after procedure completion)
- Number of participants free from Clinically-Driven Target Lesion Revascularization (CD-TLR)(12 and 24 months)
- CD-TLR-free survival(Until the end of the follow-up period of 2 years)
- Amputation-free survival(Until the end of the follow-up period of 2 years)
- Overall survival(Until the end of the follow-up period of 2 years)
- Patient-reported health-related quality-of-life(Baseline, 6, 12 and 24 months post treatment)
- Number of participants free from Clinically-Driven Target Lesion Revascularization (CD-TLR)(12 and 24 months)
- CD-TLR-free survival(Until the end of the follow-up period of 2 years)
- Number of lesions with ≤30% residual stenosis after any unplanned endovascular intervention(s)(Immediately after procedure completion)
- Need for unplanned bailout stenting(Immediately after procedure completion)
- Wound status(12 and 24 months)
- Amputation-free survival(Until the end of the follow-up period of 2 years)
- Clinical response using Rutherford classification categories(12 and 24 months)
- Patient-reported health-related quality-of-life(Baseline, 6, 12 and 24 months post treatment)
- Frequency and severity of procedural complications and other adverse events(Within 30 days after the OA procedure)
- Freedom from amputation of the target limb(12 and 24 months)
- Overall survival(Until the end of the follow-up period of 2 years)
- Clinical response using ankle-brachial index (ABI)(12 and 24 months)
- Clinical response using toe pressure(12 and 24 months)
- Clinical response using WIfi (wound, ischemia and foot infection) score(12 and 24 months)
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