NCT01759290已完成不适用
ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
研究概览
简要总结
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:
- Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
- To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s)
- 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.
详细描述
the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.).
The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.
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
- •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
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
时间窗: 0 to 407 days
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
次要结局
- All Revascularization(0 to 407 days)
- Acute Success: Clinical Device Success (Lesion Level Analysis)(< or = 1 day)
- Acute Success: Clinical Procedure Success (Per Subject Analysis)(During the hospital stay with a maximum of 3 days post index procedure)
- All Death, All MI, All Revascularization (DMR)(0 to 407 days)
- Death (Cardiovascular, Non-Cardiovascular)(0 to 407 days)
- All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).(0 to 407 days)
- Target Lesion Revascularization (TLR): All TLR(0 to 407 days)
- Target Lesion Revascularization : Ischemia-Driven (ID-TLR)(0 to 407 days)
- Acute Scaffold Thrombosis(<1 day)
- Late Scaffold Thrombosis(31 to 365 Days)
- Major Adverse Cardiac Event (MACE)(0 to 407 Days)
- Cardiac Death/All MI(0 to 407 days)
- Target Vessel Revascularization (TVR): All TVR(0 to 407 days)
- Subacute ScaffoldThrombosis(1 to 30 days)
- Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))(0 to 180 Days)
- All Death/All MI(0 to 407 days)
- Target Vessel Revascularization : Ischemic-driven (ID-TVR)(0 to 407 days)
- Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)(0 to 407 days)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Prospective Multicenter Registry for Use of the MAXFRAME™ Multiaxial Correction SystemLimb Deformities CongenitalLimb Deformities Nos (Acquired)Deformity of BoneNCT04017065AO Innovation Translation Center100
已完成
不适用
Eso-Sponge RegistryLeakage After EsophagectomyLeakage After GastrectomyPerforation of the EsophagusNCT02662777Aesculap AG108
撤回
不适用
Observational Patient Registry of the Dynamic Locking ScrewsProximal or Diaphyseal Humerus FractureDiaphyseal or Distal Femur FractureDiaphyseal, Distal or Proximal Tibia FractureNCT02656628Synthes GmbH
招募中
不适用
REFLECT Scoliosis System Post Approval StudyIdiopathic ScoliosisNCT06298812Globus Medical Inc100
Unknown
不适用
IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation RegistryVentricular ArrhythmiaPremature Ventricular Contraction (PVC)CardiomyopathyVentricular TachycardiaNCT04520347University of California, Los Angeles10,000