×
Home About
Products
Interventional Cardiology Dental Implant Systems Gastroenterology & Weight Loss Prefillable Syringes & Components Critical Care Devices Interventional Radiology OEM Services Distribution
Clinical Overview
SINEW ENOVO
Media
Events
Career

SINEW – Sirolimus Eluting Coronary Stent System

CLINICAL EVALUATION PLAN (CEP)

A structured and systematic approach for continuous evaluation of the safety and clinical performance of SINEW throughout its lifecycle in real-world clinical practice.

Co-Cr L605
Stent Platform
Biocompatible &
Biodegradable Polymer
Sirolimus
Antiproliferative Drug

AT A GLANCE

PRIMARY SAFETY ENDPOINT

MACE at 30 Days (Composite)

PRIMARY EFFICACY ENDPOINTS

MACE up to 12 Months
Device-related SAEs up to 3 Years
Stent Thrombosis (Acute, Subacute, Late up to 3 Years)

FOLLOW-UP SCHEDULE

In-hospital, 30 Days, 6 Months, 12 Months, Up to 3 Years

DATA SOURCES

PMS Data, Follow-up, Clinical Literature, Vigilance & Complaints

1 BACKGROUND

Veritas Bioventions Pvt. Ltd. has developed SINEW – Sirolimus Eluting Coronary Stent System designed for patients with coronary artery disease requiring PCI procedures.

  • Cobalt Chromium L605 Stent Platform
  • Biocompatible & Biodegradable Polymer Coating
  • Sirolimus Antiproliferative Drug

The Clinical Evaluation Plan defines the methodology for systematic evaluation of safety and clinical performance throughout the product lifecycle.

2 CLINICAL EVALUATION OBJECTIVES
2.1 Primary Objective
  • To evaluate and continuously confirm the safety and clinical performance of SINEW in real-world use.
2.2 Clinical Performance Objectives
  • Device Success Rate (%)
  • Procedural Success Rate (%)
  • Target Lesion Revascularization (TLR) rate at 12 months (%)
  • MACE rate up to 12 months (%)
  • Angiographic Stent Thrombosis rate (Acute, Subacute, Late)
2.3 Clinical Safety Objectives
  • Cardiac death
  • Myocardial infarction (Q-wave and Non Q-wave)
  • Emergent CABG
  • Clinically driven TLR/TVR
  • Device-related Serious Adverse Events (SAEs)
  • Stent thrombosis (Acute, Subacute, Late up to 3 years)
Safety will be assessed at:
In-hospital 6 months Up to 3 years 30 days 12 months
3 CLINICAL ENDPOINTS
3.1 Primary Safety Endpoint

Major Adverse Cardiac Events (MACE) at 30 days, defined as composite of:

  • Death
  • Myocardial infarction
  • Emergent CABG
  • Clinically driven TLR/TVR
3.2 Primary Efficacy Endpoints
  • MACE (%) up to 12 months
  • Device-related SAEs up to 3 years
  • Angiographic Stent Thrombosis (%):
    • Acute (In-hospital)
    • Subacute (≤ 30 days)
    • Late (>30 days to 3 years)
4 CLINICAL EVALUATION METHODOLOGY

Clinical evaluation will be based on:

  1. PMS data collected through structured PMS forms after each SINEW deployment.
  2. One-month MACE follow-up with treating cardiologist.
  3. Long-term clinical follow-up data collected every six months.
  4. Published clinical literature of Sirolimus-eluting stents.
  5. Vigilance and complaint trend data.

All collected data will be documented, reviewed, and incorporated into the Clinical Evaluation Report at defined intervals.

5 ANALYTICAL PLAN

The primary analysis will be conducted according to the intention-to-treat principle.

Descriptive statistics:

  • Count and percentage for categorical variables.
  • Mean, standard deviation, minimum and maximum for continuous variables.

MACE per patient will be ranked according to severity hierarchy:

1 Death
2 Myocardial Infarction
3 CABG
4 TLR
6 CLINICAL PERFORMANCE AND SAFETY ANALYSIS

Collected clinical data will be analyzed to determine:

  • Incidence of MACE at defined timepoints.
  • Incidence of stent thrombosis categories.
  • Incidence of device-related SAEs.
  • Trends over time

Observed results will be interpreted in the context of published outcomes for Sirolimus-eluting coronary stents to ensure that SINEW maintains an acceptable safety and performance profile.

7 IDENTIFICATION OF CLINICAL DATA GAPS

Based on currently available PMS and clinical data, the following potential data gaps have been identified:

  • Limited long-term data beyond 3 years.
  • Limited subgroup analysis in high-risk populations.
  • Limited large-scale multicenter registry data.

These gaps do not compromise the current benefit-risk assessment but require continued monitoring.

8 PMCF ACTIVITIES TO ADDRESS DATA GAPS

The following PMCF activities will address identified gaps:

  • Continued follow-up of implanted patients up to 3 years.
  • Collection of additional PMS data from multiple geographic sites.
  • Periodic literature surveillance.
  • Ongoing safety trend analysis.
9 CONCLUSION

This Clinical Evaluation Plan defines a structured and systematic approach for the ongoing evaluation of the safety and clinical performance of SINEW throughout its lifecycle.

Defined endpoints including MACE, TLR, and Stent Thrombosis rates ensure objective performance assessment and continued benefit-risk acceptability.

SINEW is committed to continuous evaluation, patient safety, and clinical excellence.

FOLLOW-UP SCHEDULE
In-hospital
30 Days
6 Months
12 Months
Up to 3 Years

This CEP is a living document and will be reviewed periodically and updated as new data, literature, and regulatory guidance become available.

*Data on file