Post marketing study to evaluate the safety and performance of Everpro Everolimus-Eluting Coronary Stent System (EES) in all-comer patients with coronary artery disease (CAD) in routine clinical practice

EverPro-REGISTRY:To determine safety and performance of Everpro Everolimus-Eluting Coronary Stent System (EES) in all-comer patients with coronary artery disease (CAD) in one year follow-Up Period.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/07/026564

Enrollment

Registered

2020-07-14

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. Males and Females more than 18 years of age. 2. Subjects who had signed the Hospital consent form. 3. The subjects who have been treated with PCI and implanted with Everpro Drug Eluting Stent as a part of their treatment of Coronary Artery Disease, without any further indication for Emergent Coronary Artery Bypass Graft Surgery

Exclusion criteria

Exclusion criteria: 1. Subjects who were not eligible for a PCI procedure. Or who were candidates for Urgent or planned elective Coronary Artery Bypass Surgery. 2. Subjects who are treated with stents other than Everpro stent. 3. Subjects who are known sensitive to Cobalt Chromium alloy, PLLA Polymer, Everolimus and its Analogues, Aspirin, Clopidogrel and analogues, and Contrast media. 4. Pregnant/lactating women during Index procedure. However, if pregnancy occurs during followâ??ups, the subject will not be excluded. 5. Subjects with more than Grade III Renal Insufficiency as indicated by Creatinine > 160 mcmol/L. 6. Subjects with short life expectancy less than the trial duration of 1 years (including patients with cancer, HIV/AIDS), documented LVEF <30%, history of Cardiac Failure, Structural heart disease, Myocardiopathies, Arrhythmia or other Comorbid conditions

Design outcomes

Primary

Measure	Time frame
To determine the safety and performance of the Everpro Everolimus-Eluting Coronary Stent System (EES) in allcomer patients with coronary artery disease (CAD) in 6 month clinical follow-upTimepoint: 6 months	—

Secondary

Measure	Time frame
1) To evaluate the Efficacy of the Device by evaluating the Frequency of Clinically Driven Target lesion Revascularization. 2) To evaluate Clinical Safety of Device in terms of Deaths and Myocardial Infarction up to 1 years. 3) To evaluate Stent Thrombosis up to 1 years from day of stent implant.Timepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Rahul Trimukhe

Atma Malik Hospital

trimukhedoc@gmail.com9921800218

Outcome results