NCT03033862
撤回
不适用
Thrombogenicity Assessment in Patients Treated With Bioresorbable Vascular Scaffolds
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Coronary Artery Disease
- 发起方
- Inova Health Care Services
- 试验地点
- 1
- 主要终点
- Change in Thrombogenicity from baseline after device implantation
- 状态
- 撤回
- 最后更新
- 5年前
概览
简要总结
Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers (fibrinogen, C-reactive protein, platelet endothelial cell adhesion molecule, von Willebrand factor, p-selectin) will be measured and compared following the implantation of Bioreabsorbable Vascular Scaffolds and Drug Eluting Stents.
研究者
入排标准
入选标准
- •Subject may be of either sex and of any race, and must be \>18 years of age.
- •Subjects undergoing elective PCI due to de novo native coronary artery lesions (length ≤24 mm) with a reference vessel diameter of ≥2.5 mm and ≤3.75 mm.
- •Subject agrees to not participate in any other investigational or invasive clinical study for a period of 3 months following the index procedure.
- •Subject must be willing and able to give appropriate informed consent.
- •The subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB).
排除标准
- •Hemodynamically unstable at the time of enrollment.
- •Concurrent or anticipated treatment with warfarin (or derivatives, e.g., phenprocoumon), oral factor Xa inhibitor, or oral direct thrombin inhibitor after enrollment.
- •GPI use prior to or at the time of PCI.
- •History of a bleeding, or evidence of active abnormal bleeding.
- •History at any time of intracranial hemorrhage, intracranial or spinal cord surgery, or a central nervous system tumor or aneurysm.
- •Documented sustained severe hypertension (systolic blood pressure \>200 mmHg or diastolic blood pressure \>110 mmHg) at enrollment.
- •Severe valvular heart disease, as defined by the American College of Cardiology /American Heart Association.
- •History within 30 days before enrollment of invasive surgeries (other than mentioned above), or is anticipating one during the course of their study participation, or is planning to have one within 1 month post dosing with the study drug.
- •History within 30 days before enrollment of TIA and ischemic (presumed thrombotic) stroke/CVA.
- •Known platelet count \<100,000/mm3 within 30 days before enrollment.
结局指标
主要结局
Change in Thrombogenicity from baseline after device implantation
时间窗: 60 Days
Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers will be measured at baseline and then reassessed at multiple time points after the implantation of the study device.
研究点 (1)
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