NL-OMON48609撤回不适用
SafePass: A prospective, non-randomized, multi-center, open-label, clinical investigation to assess the safety and technical performance of the Emboliner embolic protection catheter. - SafePass.2
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The patient must be 18 years and older.
- •2. The patient must meet the indications for the TAVR procedure.
- •3. The patient is willing to comply with protocol-specified follow-up evaluations.
- •4. The patient has been informed of the nature of the study, agrees to its provisions and has
- •provided written informed consent, approved by the appropriate Medical Ethics Committee
排除标准
- •1. Patients with an ascending aortic diameter >40 mm, or a descending aorta >27 mm.
- •2. Patients with the linear distance from the femoral access site to the aortic valve root greater
- •than 85 cm.
- •3. Patients not undergoing TAVR via the trans-femoral route.
- •4. Patients that are contraindicated for anticoagulant and/or antiplatelet therapy.
- •5. Patients with uncorrected bleeding disorders.
- •6. Pregnant or nursing subjects, or subjects who intend to become pregnant during the term of
- •7. Patients with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding
- •the index procedure (according to definition) or AMI >30 days preceding the index procedure, in whom either troponin levels, or CK (creatine kinase) and CK-MB (creatine kinase-Muscle Brain) have not returned to within normal limits at the time of procedure.
- •8. Patients with known other mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year.
- •9. Patients with severe allergy to heparin or known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, and/or contrast sensitivity that cannot be adequately pre- medicated.
- •10. Patients with a history of a stroke or transient ischemic attack(TIA) within the prior 6 months.
- •11. Patients with an active peptic ulcer or history of upper gastrointestinal(GI) bleeding within the
- •prior 3 months.
- •12. Patients with renal failure (estimated Glomerular Filtration Rate <30 mL/min, calculated from
- •serum creatinine by the Cockcroft-Gault formula).
- •13. Patients with hypercoagulable states that cannot be corrected by additional periprocedural
- •14. Patients presenting with cardiogenic shock or severe hypotension (systolic blood pressure
- •<90 mm Hg) at the time of the index procedure.
- •15. Patients with severe peripheral arterial disease that precludes delivery sheath vascular
- •access, or whose vascular anatomy is unable to accommodate a 9.5-Fr sheath.
- •16. Patients who have a planned treatment with any other investigational device or procedure
- •during the study period.
- •17. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g.,
- •concurrent coronary revascularization) during the TAVR procedure, within two (2) weeks prior
- •to the TAVR procedure, or 30 days after the TAVR procedure.
- •18. Patients with porcelain aorta, asymmetrical or sharp aortic calcifications, high grade aortic
- •stenosis, or torsion of the aorta.
- •19. Emergency patients.
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