An Evaluation the â??Real Worldâ?? Clinical Performance in India of the MGuardâ?¢ Coronary Stent System A Prospective, Observational, Multicenter Registry - LIFECARE

Kirloskar Technologies P Ltd0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patient is > 18 years of age
•2. Patient has a documented STEMI
•3. The patient has consented to participate by signing the Patient Data Release Form or the Patient Informed Consent Form
•4. Patient is suitable for implantation of one or more MGuard Stent System in one or more target lesions
•5. Target lesion(s) are according to the Indications for Use as mentioned in the Instructions for Use of the MGuard Stent System
•6. The patient is willing and able to cooperate with registry procedures and required follow up

•1. Heavily calcified target lesions
•2. Target lesions with side branch bigger then 2.0 mm
•3. Target lesions which are distal to newly stented lesion (less than 1 month).
•4. Women with known pregnancy
•5. Current medical condition with a life expectancy of less than 12 months
•6. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits study participation

发起方

Kirloskar Technologies P Ltd