Evaluation of Pharmacokinetic (PK) and safety of the Supralimus-Core(TM) Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions.

Sahajanand Medical Technologies Pvt Ltd0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

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. Age grater than or equal to18 years.
•2. Eligible for percutaneous coronary intervention (PCI).
•3. Acceptable candidate for CABG.
•4. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.
•5. The target lesion is a single de novo coronary artery lesion with grater than or equal to 50% and less than 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.
•6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
•7. The target lesion must be grater than or equal to 33 mm in length by visual estimate.
•8. The target reference vessel diameter must be grater than or equal to 2.25 mm and less than or equal to 4.0 mm.
•9. Patient or patients legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as notified / approved by the Institutional Review Board/Ethics Committee of the clinical site.

排除标准

•1. Female of childbearing potential.
•2. Documented left ventricular ejection fraction (LVEF) less than or equal to 25%.
•3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
•4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix(R), Ceruvin) or ticlopidine (Ticlid(R)), heparin, sirolimus, stainless steel, contrast agent (that cannot be adequately pre-medicated).
•5. A platelet count less than 100,000 cells/mm3 or grater than 700,000 cells/mm3 or a WBC less then 3,000 cells/mm3.
•6. Acute or chronic renal dysfunction (creatinine grater then 2.0mg/dl or grater than150Âµmol/L).
•7. Target vessel has evidence of thrombus.
•8. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment.
•9. Previous bare metal stenting (less than 1 year) anywhere within the target vessel.
•10. Previous drug-eluting stenting anywhere within any epicardial vessel.
•11. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
•12. Significant (grater than 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off.
•13. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated.
•14. Target lesion is located in or supplied by an arterial or venous bypass graft.
•15. Ostial target lesion.
•16. Patient is currently participating in an investigational drug or device study, including its follow-up period.
•17. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind.
•18. Within 48 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
•19. CVA within previous 6 months.
•20. Unprotected Left Main (LM) coronary artery disease (stenosis grater than 50%).
•21. In the investigators opinion, patient has a co-morbid condition(s) that could limit the patients ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
•22. Planned surgery within 48 days after the index procedure
•23. Life expectancy less than 1 year
•24. Any contraindication to blood sampling.

研究者

发起方

Sahajanand Medical Technologies Pvt Ltd

相似试验

进行中（未招募）

不适用

An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescentsobese children and adolescents of Caucasian descent with insulin resistance in the age of = 10 and = 16 years at study entry.

EUCTR2010-023980-17-NLSt. Antonius Hospital

已完成

3 期

An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents.Bariatrie (Obesitas)excess body fatObese

NL-OMON39499Sint Antonius Ziekenhuis144

已完成

不适用

An Evaluation of the Safety and Pharmacokinetics of Posaconazole (POS, SCH 56592) IV Solution via Peripheral Administration in Healthy Volunteers (P06356)Fungal infections10017528

EUCTR2010-020832-20-NLSchering-Plough Research Institute, a Division of Schering Corporation - for Global trials96

尚未招募

1 期

Safety and pharmacokinetics of CIGB-552Solid tumors

RPCEC00000196Center for Genetic Engineering and Biotechnology (CIGB)