To evaluate safety and performance of the BioMimeâ?¢- Sirolimus Eluting Coronary Stent System in the treatment of patients during a pre-defined period.

A Retrospective study of consecutive patients treated with BioMimeâ?¢ â?? Sirolimus Eluting Coronary Stent System during a pre-defined period. - MeriT-lll A

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/10/009968

Enrollment

1161

Registered

2017-10-03

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: I259- Chronic ischemic heart disease, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient is 18 Year old. 2. Patients who have been implanted with BioMime Sirolimus Eluting Coronary Stent System between January-2010 to February-2011. 3. The patient and/or his legal representative have provided a hospital written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have not been implanted with BioMime• â?? Sirolimus Eluting Coronary Stent System. 2. Patients who have been implanted with BioMime• â?? Sirolimus Eluting Coronary Stent System before and after January-2010 to February-2011

Design outcomes

Primary

Measure	Time frame
1.month clinical/telephonic follow-up and 6 months clinical/ telephonic follow-up. The secondary endpoint of this study is to evaluate the MACE events at 12 months clinical/ telephonic follow-up. For this study Major Adverse Cardiac Event (MACE) is defined as a composite of: 1. Death 2. Myocardial Infarction (MI) 3. Coronary Artery Bypass Graft (CABG) surgery 4. Target Lesion Revascularisation (TLR) 5. Target Vessel Revascularisation (TVR) and 6. Stent Thrombosis (ST)Timepoint: 1 month, 6 months and 12 months clinical/telephonic follow-up data will be recorded in a pre-approved Case Report Form, and a safety analysis report will be prepared based on the above recorded parameters.	—

Measure

Time frame

1.month clinical/telephonic follow-up and 6 months clinical/ telephonic follow-up. The secondary endpoint of this study is to evaluate the MACE events at 12 months clinical/ telephonic follow-up. For this study Major Adverse Cardiac Event (MACE) is defined as a composite of: 1. Death 2. Myocardial Infarction (MI) 3. Coronary Artery Bypass Graft (CABG) surgery 4. Target Lesion Revascularisation (TLR) 5. Target Vessel Revascularisation (TVR) and 6. Stent Thrombosis (ST)Timepoint: 1 month, 6 months and 12 months clinical/telephonic follow-up data will be recorded in a pre-approved Case Report Form, and a safety analysis report will be prepared based on the above recorded parameters.

—

Secondary

Measure	Time frame
The secondary endpoint of this study is to evaluate the MACE events at 12 months clinical/ telephonic follow-up.Timepoint: The secondary endpoint of this study is to evaluate the MACE events at 12 months clinical/ telephonic follow-up.	—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Meril Life Sciences Pvt Ltd

ashok.thakkar@merillife.com9879443584

Outcome results