Clinical Investigation for Everolimus Drug Eluting Stent

NCT06769217 | Completed Phase 4 Results DMC

• 1 other identifier: ESC/FM/030622
• Study Type: interventional
• Target: 888
• Locations: 2 countries
• Sites: 5

Brief Summary

History of Device Development and Study Rationale: Drug-eluting stents (DES) revolutionized percutaneous coronary intervention (PCI) by significantly reducing restenosis and the need for repeat procedures compared to bare-metal stents (BMS). Introduced in the early 2000s, DES quickly became the standard of care due to its superior antiproliferative properties. DES consists of a metal stent, an antiproliferative drug, and a polymer coating. The stent provides structural support while the drug is gradually released to inhibit tissue growth within the artery. This dual action effectively prevents restenosis, a common complication after PCI. Contemporary guidelines strongly recommend DES over BMS for various clinical scenarios. The proven efficacy and safety of current-generation DES make them the preferred treatment option for patients undergoing PCI. First-generation drug-eluting stents: First-generation drug-eluting stents (DES) marked a significant advancement in interventional cardiology, addressing the persistent issue of in-stent restenosis (ISR) associated with bare-metal stents (BMS). These innovative devices, composed of a metal frame, an antiproliferative drug (sirolimus or paclitaxel), and a polymer coating, were designed to release the drug gradually, preventing tissue growth within the artery. Clinical trials demonstrated the superior efficacy of DES over BMS in reducing ISR and target lesion revascularization (TLR). The RAVEL trial, for example, found a dramatic decrease in ISR with sirolimus-eluting stents (SES). Subsequent studies and meta-analysis confirmed the benefits of both SES and paclitaxel-eluting stents (PES) compared to BMS, particularly in high-risk patients. The introduction of DES represented a paradigm shift in interventional cardiology, offering a more effective and durable solution for patients with coronary artery disease. Second-generation drug-eluting stents: Second-generation drug-eluting stents (DES) were developed to address the safety concerns associated with first-generation DES, such as stent thrombosis (ST), incomplete endothelialization, and polymer-induced inflammation. These newer stents incorporate less toxic drugs, more biocompatible coatings, and thinner, more flexible struts. Clinical trials have demonstrated the superior safety and efficacy of second-generation DES compared to their predecessors. Studies comparing everolimus-eluting stents (EES) and zotarolimus-eluting stents (ZES) to first-generation DES have shown significant reductions in ST, myocardial infarction (MI), and target lesion revascularisation (TLR). Head-to-head comparisons of EES and ZES have also revealed comparable outcomes in real-world patient populations. Both stents are effective and safe for the treatment of obstructive coronary artery disease, making them the preferred choice for percutaneous coronary intervention. Study Rationale: The introduction of drug-eluting stents (DES) marked a significant leap in interventional cardiology by addressing the limitations of bare-metal stents (BMS), primarily through reducing restenosis and the need for repeat procedures. First-generation DES, equipped with antiproliferative drugs like sirolimus and paclitaxel, demonstrated superior efficacy in preventing in-stent restenosis. However, safety concerns, including stent thrombosis and polymer-induced inflammation, led to the development of second-generation DES, which utilizes more biocompatible materials and refined designs. Clinical trials have consistently shown that these newer DES offer enhanced safety and effectiveness, solidifying their position as the preferred treatment option in percutaneous coronary interventions. Study Objectives The main objective of this study is to assess the safety and effectiveness of the EvroSure Everolimus Drug eluting CoCr stent in obstructive coronary artery disease. Primary Objective The primary endpoint of this study is to monitor Major Adverse Cardiac Events (MACE) at 30 days. Secondary Objective The following secondary effectiveness endpoints are as follows:

• Angiographic/device success (%)
• Procedural success (%)
• Clinically justified Target Lesion Revascularization (TLR) (%) at 12 months The following secondary safety endpoints are:
• MACE (%) until 12 months (Clinically Justified)
• Device-related SAEs until 12 months (Clinically Justified) Note: MACE rate is defined as the incidence of the combined clinical endpoint: Composite of Death (Cardiac death as well as Non-Cardiac), Myocardial Infarction (Q-wave and non-Q-wave), Emergency Coronary Artery Bypass Graft Surgery, clinically justified TLR following index procedure.

Conditions

Coronary Arterial Disease (CAD)

Keywords

A Prospective Multi-Centre Registry for Everolimus Drug Eluting CoCr Coronary Stent

Outcome Measures

Primary Outcomes (1)

• 888 Number of Participants With Major Adverse Cardiac Events (MACE) at 30 Days

  The primary endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days. Note: MACE rate is defined as the incidence of the combined clinical endpoint: Composite of Death (Cardiac death as well as Non-Cardiac), Myocardial Infarction (Q-wave and non-Q-wave), Emergency Coronary Artery Bypass Graft Surgery, clinically justified TLR within 30 days following index procedure.

  30 days

Secondary Outcomes (1)

• • MACE (%) Until 12 Months • Device-related SAEs Until 12 Months

  12 month

Study Arms (1)

Single Arm

OTHER

Its a single arm multicenter registry to investigate safety and efficacy of product by clinical follow up at one month and 12 month

Device: Drug Eluting Coronary Stent

Interventions

Drug Eluting Coronary Stent DEVICE

The Drug Eluting Coronary stent is indicated for the treatment of de novo coronary artery lesions in patients with symptomatic ischemic heart disease.

Single Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be ≥ 18 years of age;
• Patient was an acceptable candidate for PTCA, Stenting, or Emergent CABG;
• Patient has clinical evidence of ischemic heart disease or a positive functional study
• Patient and his or her treating physician agree that the patient will comply with all the required post-procedure follow-up.
• Target lesion(s) present with ≥50% stenosis, in one or more vessels
• Target lesions have to be de novo;
• One or more target lesions require treatment
• Reference vessel diameter of target lesion(s) must be ≥ 2.25mm and ≤ 4.5mm, by visual estimate

You may not qualify if:

• Previous PTCA with any stent
• History of CVA or TIA within the last 3 months
• Patient has active infection
• Concurrent medical condition with a life expectancy of less than 12 months
• Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, or ticlopidine including thrombocytopenia, neutropenia, or leukopenia
• Active peptic ulcer or upper gastrointestinal bleeding.
• Current participation in an investigational drug or device trial that has not completed its primary endpoint follow-up period.
• Pregnancy or woman of childbearing potential who, in the opinion of the investigator, does not take adequate measures to prevent conception.
• Known hypersensitivity or contraindication to cobalt, chromium, or nickel

Sponsors & Collaborators

• Frisch Medical Device Private Limited: lead

Study Sites (5)

Baroda Heart Institute & Research Centre

Vadodara, Gujarat, 390007, India

Location

Medical College & Hospital

Bangalore, Karnataka, India

Location

Hospital (P) Ltd.

Kozhikode, Kerala, 673002, India

Location

Grandmed Lubuk Pakam Hospita

Tanjung Morawa, North Sumatra, Indonesia

Location

Primaya Tangerang

Jakarta, Indonesia

Location

Results Point of Contact

• Title: Nidhi Mishra
• Organization: Frisch Medical Devices PVT LTD

REGULATORY_1@frischmedical.com

00917948006239

Study Officials

• Bhavin Oza, Bsc

  Frisch Medical Devices

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 10, 2025
• Study Start: January 1, 2023
• Primary Completion: November 8, 2024
• Study Completion: January 30, 2025
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: IPD can be shared from 30th January 2025 till 29th January 2026
• Access Criteria: Any cardiologist, researcher or author of reputed journals will be able to access, protocol and CER. SomeOne who needs access has to email to frischmedical@gmail.com

Locations

ID (2); IN (3)