A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,005
- 试验地点
- 24
- 主要终点
- Death (Cardiovascular, Non-Cardiovascular)
研究概览
简要总结
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
详细描述
ABSORB UK registry is a prospective, single arm, post-market registry designed to:
- Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
- Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:
- •Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- •Patient is to be treated for de novo lesions located in previously untreated vessels.
- •Patient must agree to undergo all required follow-up visits and data collection.
排除标准
- •The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:
- •Inability to obtain a signed informed consent from potential patient.
- •Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).
结局指标
主要结局
Death (Cardiovascular, Non-Cardiovascular)
时间窗: 3 year
Myocardial Infarction (MI)
时间窗: 1 year
Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)
Target Vessel Revascularization (TVR)
时间窗: 1 year
all TVR
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
时间窗: 3 year
MI
时间窗: 3 year
Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)
Scaffold/Stent Thrombosis
时间窗: 3 year
Definite, Probable
TVR
时间窗: 3 year
ID-TVR
Acute Success: Device success (lesion based analysis)
时间窗: From the start of index procedure to end of index procedure
Achievement of a final in-scaffold residual diameter stenosis of \< 50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device is considered to have failed if it did not meet the requirements of the definition for clinical device success.
Target Lesion Revascularization (TLR)
时间窗: 1 year
all TLR
Acute Success: Procedural success (patient based analysis)
时间窗: From the start of index procedure to end of index procedure
Achievement of a final in-scaffold diameter stenosis of \< 50% by online QCA or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.
TLR
时间窗: 3 year
ID-TLR
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
时间窗: 3 year
Cardiac Death/All MI/ID-TLR (MACE)
时间窗: 3 year
次要结局
未报告次要终点