Esprit BTK Post-Approval Study (Esprit BTK PAS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 70
- 主要终点
- Primary Effectivenes Endpoint(s): Freedom from clinically-driven target lesion revascularization (CD-TLR)
研究概览
简要总结
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •General Inclusion Criteria
- •Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site.
- •Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first.
- •Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.
- •Subject must be at least 18 years of age.
- •Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
- •Anatomic Inclusion Criteria
- •Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm.
- •Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels.
排除标准
- •General Exclusion Criteria
- •Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).
- •Subject is currently participating in another clinical investigation.
- •Subject is unable or unwilling to provide written consent prior to enrollment.
- •Subject with life expectancy ≤ 1 year.
- •Subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation.
- •Anatomic Exclusion Criteria
- •Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure.
- •Subject had been previously treated with Esprit BTK Scaffold(s).
结局指标
主要结局
Primary Effectivenes Endpoint(s): Freedom from clinically-driven target lesion revascularization (CD-TLR)
时间窗: At 1 year
This effectiveness endpoint was chosen because it allows to assess whether Esprit BTK is effective at maintaining patency (CD-TLR).
Primary Safety Endpoint(s):MALE at 6 months + POD at 30 days (Major Adverse Limb Event + Peri-Operative Death)
时间窗: 6 months + 30 days
This safety endpoint was chosen because it is a commonly used endpoint to assess the safety of devices used in lower limb treatment, including treatment of lesions below the knee. Additionally, this endpoint assesses whether the device is associated with acute and sub-acute harm such as death and limb loss.
次要结局
- All-cause mortality(Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years)
- Amputation (minor, major)(Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years)
- Amputation-free survival(Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years)
- Ankle-Brachial Index (ABI)/Toe-Brachial Index (TBI) progression over time(Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years)
- Rutherford Becker category evolution over time(Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years)
- Wound healing, as assessed by investigator(Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years)