FindTrial
Sign In

Prospective Clinical evaluation of Drug Eluting Coronary Stents

A Prospective, Single Centre, Observational, 12-months follow-up, clinical evaluation study to investigate the safety and performance of the M Sure-S, Sirolimus Eluting Coronary Stent System in coronary artery lesion. - PRISM-1

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098464
Enrollment
200
Registered
2025-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: I20- Angina pectoris Health Condition 2: I219- Acute myocardial infarction, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Multimedics LLP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient with an age greater than 18 years

Exclusion criteria

Exclusion criteria: 5. The subject is participating in another device or drug study. 6. Female patients with a known pregnancy or who are lactating. 7. Current medical condition with a life expectancy of less than 12months.

Design outcomes

Primary

MeasureTime frame
To prospectively analyze the safety profile of the M Sure-S, Sirolimus Eluting Coronary Stent in patients who underwent percutaneous coronary intervention (PCI) for coronary artery lesions.Timepoint: 6 month, 9 month and 12 month—

Secondary

MeasureTime frame
To prospectively evaluate the performance of the M Sure-S, Sirolimus Eluting Coronary Stent in terms of major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), and clinical outcomes at 12-months follow-up.Timepoint: 6 month, 9 month and 12 month—

Countries

India

Contacts

Public ContactDr Mahesh Nalin Kumar

St Gregorios Medical Mission Multi-Specialty Hospital

drnkmahesh@gmail.com7042279191

Outcome results

None listed

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