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Clinical Trials/CTRI/2013/01/003313
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

Investigators

Sponsor
Kirloskar Technologies P Ltd

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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