NL-OMON55926已完成3 期
The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de novo Native Coronary Artery Lesions - DESyne BDS Plus RCT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
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. Patient must be at least 18 years of age
- •2. Patient is able to understand the risks, benefits and treatment alternatives
- •of receiving the DESyne BDS Plus DECSS or the DESyne X2 NECSS and provide
- •written informed consent or oral consent (in urgent PCI) as allowed per
- •hospital standard and as approved by the local Ethics Committee, prior to any
- •clinical study-related procedure
- •3. Indication for a percutaneous intervention with stent implantation in native
- •epicardial arteries including patients with stable coronary artery disease and
- •acute coronary syndromes including NSTEMI and STEMI.
- •If patient is presenting with STEMI, enrollment should take place only if
- •sufficient research staff is available and the center is trained to perform PCI
- •in an acute setting
- •4. Patient must be an acceptable candidate for coronary artery bypass graft
- •(CABG) surgery
- •5. Patient agrees to undergo all clinical study required follow up visits,
- •angiograms, and imaging testing (as applicable)
- •6. Patient agrees not to participate in any other clinical research study for a
- •period of one year following the index procedure (long term follow-up or
- •observational studies are permitted)
- •Angiographic Inclusion Criteria
- •7. Target lesion(s) must be de novo coronary artery lesion(s) and must be
- •located in a separate* vessel from other target or non-target lesions.
- •If a non-target lesion is present, it must have been treated successfully and
- •without complication** prior to proceeding with treatment of the target lesion
- •8. Target lesion(s) must have a reference vessel diameter (RVD) of >= 2.25 and <=
- •3.5 mm by visual estimation
- •9. Target lesion(s) must measure <= 34 mm in length, and able to be covered by a
- •single device with 2 mm of healthy vessel on either side of planned
- •implantation site
- •10. Target lesion(s) must be in a major artery or branch with a visually
- •estimated stenosis of >= 50% and <100%. When two target lesions are treated,
- •they must be located in separate major epicardial vessels
- •*The definition of epicardial vessels is the LAD, LCx and RCA, and is inclusive
- •of their branches. For example, the patient must not have lesions requiring
- •treatment in both the LAD and a diagonal branch.
- •**Assessment of successful treatment of the non-target lesion will be per
- •physician*s decision, however, acute complications and/or adverse events
- •associated with the non-target lesion should be considered unsuccessful.
- •Examples of unsuccessful treatment include but are not limited to: inability to
- •deploy stent, major dissection requiring multiple stent placement, stent
- •embolization, ST, prolonged chest pain, persistent ECG changes, etc.
- •Additional Inclusion Criteria for PK study:
- •11. Patients participating in PK study may be treated with only the DESyne BDS
- •Plus during Index Procedure.
排除标准
- •1. Acute myocardial infarction with Killip Class III and IV
- •2. Acute myocardial infarction requiring resuscitation
- •3. Acute myocardial infarction requiring IABP or ventilation support
- •4. Patient had fibrinolysis prior to PCI
- •5. Patient has current unstable ventricular arrhythmias
- •6. Patient has a known left ventricular ejection fraction (LVEF) < 30%
- •7. Patient has received a heart transplant or any other organ transplant or is
- •on a waiting list for an organ transplant
- •8. Patient is receiving or scheduled to receive chemotherapy for malignancy
- •within 30 days prior to or after the procedure
- •9. Patient is receiving immunosuppression therapy, other than steroids or has
- •known immunosuppressive or autoimmune disease (e.g., human immunodeficiency
- •virus, systemic lupus erythematosus, etc.)
- •10. Patient has a known hypersensitivity or contraindication to aspirin, both
- •heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Novolimus,
- •Sirolimus, Rivaroxaban, Argatroban, CoCr alloys, PLLA polymers or contrast
- •sensitivity that cannot be adequately pre-medicated
- •11. Elective surgery is planned within the first 6 months after the procedure
- •that will require discontinuing either aspirin or clopidogrel or other P2Y12
- •12. Patient has severe renal dysfunction (CKD IV or V, eGFR <30) or is on
- •13. Patient has had a cerebrovascular accident (CVA) or transient ischemic
- •neurological attack (TIA) within the past six months
- •14. Patient has had a significant GI or urinary bleed within the past six months
- •15. Women of childbearing potential (unless they have a negative pregnancy test
- •within 7 days of index procedure), or women who are pregnant or nursing
- •16. Patient has other medical conditions or known history of substance abuse
- •(alcohol, cocaine, heroin, etc.) that may cause non-compliance with the
- •clinical study plan, confound the data interpretation, or be associated with a
- •limited life expectancy (i.e., less than one year)
- •17. Patient is already participating in another clinical study which has not
- •reached the primary endpoint (long-term follow-up or observational studies are
- •Angiographic Exclusion Criteria
- •18. Patient with vessel rupture and/or visible pericardial effusion
- •19. Target lesion aorto-ostial location or within 5mm of the origin of the
- •vessel (LAD, LCX, RCA)
- •20. Target lesion is severely calcified and/or requires use of rotational
- •atherectomy or cutting balloon, the use of scoring is allowed
- •21. Target Lesion located in the Left Main artery
- •22. Target Lesion located within an arterial or saphenous vein graft or distal
- •to a diseased arterial or saphenous vein graft
- •23. Target Lesion involves a bifurcation >2.5 mm, or which requires a planned 2
- •or more stent technique
- •24. Previous placement of a stent within 10 mm of a target lesion
- •25. Another clinically-significant lesion (> 50%) is located in the same major
- •epicardial vessel as a target lesion
- •26. Target vessel was previously treated with any type of PCI < 6 months prior
- •to index procedure
- •27. Unsuccessful or complicated PCI in a non-target vessel < 48 hours prior to
- •index procedure
- •28. Target vessel has a planned staged PCI <= 6 months after the index procedure
- 另有 2 项未显示
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