CTRI/2013/01/003313
Other
Phase 4
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 sites1,000 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kirloskar Technologies P Ltd
- Enrollment
- 1000
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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