CTRI/2011/12/002302进行中（未招募）3 期
Study to evaluate safety and efficacy of FOCUSnp Sirolimus based nano carrier eluting coronary stent system for treatment of patients with single de novolesions in native coronary artery lesions. - NANOACTIVE FIM-I
Envision Scientific Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
入选标准
- •1.De novo lesions in native coronary arteries.
- •2.Reference diameter is greater than 2.50 and is less than or equal to 3.50 mm (visual estimation).
- •3.Lesion length 10 mm less than or equal to Lesion Length is less than or equal to 24 mm (visual estimation).
- •4.Single lesion per vessel.
- •5.Maximum two lesions per patient.
- •6.All lesions must be treated with the same study device (FOCUSnp•).
- •7.The patient is at least 18 years of age.
- •8.The patient has clinical evidence of ischemic heart disease,stable or unstable angina,silent ischemia,or a positive functional trial.
- •9.The patient is an acceptable candidate for percutaneous trans luminal coronary angioplasty (PTCA),stenting,and emergent coronary artery bypass graft (CABG) surgery.
- •10.Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
- •11.The patient or patientâ??s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site.
- •12.The patient agrees to return to the same research facility for all required post-procedure follow-up visits.
排除标准
- •1.Bifurcation lesion(s) including left main,Target lesion with Ostial location (within 5 mm of Ostium by visual assessment),Target lesion with lateral side branch is greater than 2.5 mm or requiring lateral branch stenting.
- •2.Moderate to severely calcified lesions(visual estimation)
- •3.Severe tortuous lesions or with proximal angulation (greater than 90 degrees) or at a greater than 45 degree bend in the vessel.
- •4.Documented left ventricular ejection fraction (LVEF) less than 30 percent at most recent evaluation.
- •5.A known hypersensitivity or contraindication to aspirin,heparin or bivalirudin,Ticlopidine or clopidogrel,cobalt chromium or stainless steel alloys,polymer coatings,contrast media,which cannot be adequately pre-medicated.
- •6.History of an allergic reaction or significant sensitivity to Sirolimus or drugs in similar class.
- •7.Chronic total occlusion (CTO) or Presence of visible thrombus in target vessel.
- •8.A serum creatinine level greater than 2.0 mg/dl within seven days prior to index procedure.
- •9.Evidence of an acute MI within 72 hours of the intended index procedure (defined as: QWMI or non-Q wave myocardial infarction (NQWMI) having CK enzymes greater than 2X the upper laboratory normal with the presence of a CK-MB elevated above the Institutionâ??s upper limit of normal).
- •10. Platelet Count less than 1000,000 cells/mm3 or greater than 700,000 cells/mm3,White blood cell count 3,000 cell/mm3,Hepatic disease(suspected or documented including laboratorial evidence of hepatitis).
- •11.The stent covers beyond the lesion proximally and distally with less than 2 mm (visual).
- •12.Previous PCI of the target lesion.
- •13.Previous PCI of the target vessel within 9 months pre-procedure.
- •14.Planned PCI of any vessel within 90 days post-procedure.
- •15.Surgery 30 days prior this PCI or anticipated surgery 6 months post this PCI.
- •16.During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement (including but not limited to,cutting balloon,any atherectomy,any laser,thrombectomy,etc.).
- •17.Second lesion requiring treatment in target vessel.
- •18.History of a stroke or transient ischemic attack (TIA) within the prior 6 months.
- •19.Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- •20.History of bleeding diathesis or coagulopathy or will refuse blood transfusions or under Phenprocoumon or Cumarine therapy.
- •21.Concurrent medical condition with a life expectancy of less than 12 months.
- •22.Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy.
- •23.Currently participating in an investigational drug or another device trial that interferes with the current trial endpoints;or requires coronary angiography, IVUS or other coronary artery imaging procedures.
- •24.Any contraindications as mentioned in the FOCUSnp• Instructions for Use (IFU).
研究者
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