Indian MGuard Registry: An Indian registry in which data will be collected of patients who are suitable for stenting and who will be treated with one or more MGuardâ?¢ stents.

Phase 4

• Conditions: Health Condition 1: null- ST Elevation Myocardial Infarction (STEMI)

• Registration Number: CTRI/2013/01/003313
• Lead Sponsor: Kirloskar Technologies P Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 1000

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

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ischemic related Major Adverse Cardiac Events rate (MACE)Timepoint: 30 Days

Secondary Outcome Measures

Name	Time	Method
1. Ischemic related Major Adverse Cardiac Events rate (MACE) at Discharge, 6 Months and 01 Year <br/ ><br> <br/ ><br>2. Stent thrombosis rate (acute: 24 h; sub acute: 2-30 days; late: 30 days-1 year) <br/ ><br> <br/ ><br>3. Bleeding complications (procedural, discharge, 30 days 6 months and 1 year) <br/ ><br> <br/ ><br>4. Any death and cardiac death <br/ ><br> <br/ ><br>5. Procedural success rate <br/ ><br> <br/ ><br>6. Clinical success rate <br/ ><br> <br/ ><br>7. Lesion success rate <br/ ><br> <br/ ><br>8. Perfusion Outcomes (TIMI flow, ST resolution)Timepoint: Up to 1 Year