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.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/01/003313

Enrollment

1000

Registered

2013-01-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: NIL: NIL Intervention2: MGuard(TM)Coronary Stent System: All STEMI patients with an indication for implantation of MGuard Coronary Stent System according to the â??Instructions for Useâ

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Ischemic related Major Adverse Cardiac Events rate (MACE)Timepoint: 30 Days	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactMr Renny Mathew

Vibgyor Scientific Research Pvt. Ltd.

bina.naik@vibgyorcare.com079-26565076

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026