REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Number of lesions free from Clinically-Driven Target Lesion Revascularization (CD-TLR)
研究概览
简要总结
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.
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 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.
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 ORACLE (ClinicalTrials.gov ID NCT07270562).
研究组 & 干预措施
Adult CLTI patients with infrapopliteal calcified lesions
Adult CLTI patients planned to receive the Esprit BTK™ resorbable scaffold following pre-dilatation with angioplasty balloon.
干预措施: Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott (Device)
结局指标
主要结局
Number of lesions free from Clinically-Driven Target Lesion Revascularization (CD-TLR)
时间窗: 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.
次要结局
- Clinical response using WIfi (wound, ischemia and foot infection) score(12, 24, and 36 months)
- CD-TLR-free survival per target lesion(Until the end of the follow-up period of 3 years)
- Clinical response using Rutherford classification categories(12, 24, and 36 months)
- Amputation-free survival(Until the end of the follow-up period of 3 years)
- Overall survival(Until the end of the follow-up period of 3 years)
- Patient-reported health-related quality-of-life(Baseline, Day 0 (day of procedure), 6-, 12-, 24-, 26-months post treatment)
- Frequency and severity of procedural complications and other adverse events(Within 30 days after the index procedure)
- Frequency of major adverse limb events (MALE) and peri-operative death (POD).(6 months for MALE; Within 30 days after the index procedure for POD)
- Clinical response using ankle-brachial index (ABI)(12, 24, and 36 months)
- Clinical response using toe pressure(12, 24, and 36 months)
- CD-TLR-free survival per target lesion(Until the end of the follow-up period of 3 years)
- Clinical response using Rutherford classification categories(12, 24, and 36 months)
- Wound status(12, 24, and 36 months)
- Freedom from major amputation of the target limb(12 and 24 months)
- Amputation-free survival(Until the end of the follow-up period of 3 years)
- Overall survival(Until the end of the follow-up period of 3 years)
- Patient-reported health-related quality-of-life(Baseline, Day 0 (day of procedure), 6-, 12-, 24-, 26-months post treatment)
- Frequency and severity of procedural complications and other adverse events(Within 30 days after the index procedure)
- Frequency of major adverse limb events (MALE) and peri-operative death (POD).(6 months for MALE; Within 30 days after the index procedure for POD)
- Clinical response using ankle-brachial index (ABI)(12, 24, and 36 months)
- Clinical response using toe pressure(12, 24, and 36 months)
- Clinical response using WIfi (wound, ischemia and foot infection) score(12, 24, and 36 months)
- Restoration of normal lumen per target lesion(Immediately upon procedure completion)