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Retrospective study to perform the safety and performance of Neohexa-Sirolimus-Eluting Coronary Stent in all patients with coronary artery disease

A Retrospective, Observational Study to Determine Safety and performance of Neohexa-Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/10/046402
Enrollment
1500
Registered
2022-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: - Health Condition 2: I248- Other forms of acute ischemic heart disease

Interventions

None listed

Sponsors

Sahajanand Laser Technology Ltd
Lead Sponsor

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 Neohexa Drug-Eluting Stent as a part of their treatment of Coronary Artery Disease without any further indication for emergent coronary artery bypass graft surgery 4. Patients who have completed a minimum of 24 months after device implantation (device implanted between 01-01-2017 to 31-12-2019)

Exclusion criteria

Exclusion criteria: 1. Subjects who are treated with stents other than Neohexa stent in the same vessel. 2. Subjects implanted with Neohexa stent after 31-12-2019

Design outcomes

Primary

MeasureTime frame
Cumulative MACE at time of follow-up. MACE is defined as a composite of cardiac death, myocardial infarction and target lesion revascularization. Sustained relief in angina/ angina equivalent symptoms at the time of follow-up without need for target lesion revascularizationTimepoint: 2 years

Secondary

MeasureTime frame
Individual components of MACE all-cause mortality, target vessel revascularization, and stent thrombosis. stent thrombosis shall be further divided as definite, probable, and possible ST as defined by the academic research consortiumTimepoint: 2 years

Countries

India

Contacts

Public ContactPreeti Vani

Govind Ballabh Pant Institute of Postgraduate Medical Education and Research

safal.007@rediffmail.com9718592497

Outcome results

None listed

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