Coronary Arterial Disease (CAD)Phase 4EverGreenNCT06769217
Clinical Investigation for Everolimus Drug Eluting Stent
A Phase 4 study testing Drug Eluting Coronary Stent in people with Coronary Arterial Disease (CAD), run by Frisch Medical Device Private Limited at 5 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Drug Eluting Coronary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 888 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jan 2023to 30 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
India3 sites
Medical College & Hospital
Bangalore, Karnataka
Hospital (P) Ltd.
Kozhikode, Kerala, 673002
Baroda Heart Institute & Research Centre
Vadodara, Gujarat, 390007
Indonesia2 sites
Primaya Tangerang
Jakarta
Grandmed Lubuk Pakam Hospita
Tanjung Morawa, North Sumatra
About this study
Official title: A Prospective Multi-Centre Registry of EvroSure (Everolimus Drug Eluting CoCr Coronary Stent) to Investigate Safety and Effectiveness Name of Study: EverGreen
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.
Read more
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.
Read the detailed description
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.
Study Endpoints
Primary endpoints
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.
Secondary endpoints
The secondary effectiveness endpoints were as follows:
- Angiographic/device success (%) (Angiographic device success is determined by confirming the accurate placement of the device within the targeted coronary arteries through X-ray examination.)
- Procedural success (%) (Procedural success is determined by successful implantation of the stent and clearance of blockage.)
- Clinically justified Target Lesion Revascularization (TLR) (%) at 12 months
The following secondary safety endpoints were assessed:
- MACE (%) until 12 months (Clinically Justified)
- Device-related SAEs until 12 months (Clinically Justified)
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Drug Eluting Coronary Stent
- Keywords
- A Prospective Multi-Centre Registry for Everolimus Drug Eluting CoCr Coronary Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting Coronary StentDevice
The Drug Eluting Coronary stent is indicated for the treatment of de novo coronary artery lesions in patients with symptomatic ischemic heart disease.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Drug Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
• MACE (%) Until 12 Months • Device-related SAEs Until 12 Months
Angiographic success 100% Procedural success was demonstrated by restored TIMI grade 3 flow 97.07% Early device-related serious adverse events 0
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2023
- Primary completion8 Nov 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisch Medical Device Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhavin Oza, Bsc, Study chair, Frisch Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769217
- Sponsor's protocol ID
- ESC/FM/030622
- Acronym
- EverGreen
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2025
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Results
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Centre Registry of EvroSure (Everolimus Drug Eluting CoCr Coronary Stent) to Investigate Safety and Effectiveness Name of Study: EverGreen
- ClinicalTrials.gov ID
- NCT06769217
- Acronym / sponsor ID
- EverGreen / ESC/FM/030622
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- A Prospective Multi-Centre Registry for Everolimus Drug Eluting CoCr Coronary Stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- Frisch Medical Device Private LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 10 Jan 2025 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study Endpoints
Primary endpoints
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.
Secondary endpoints
The secondary effectiveness endpoints were as follows:
- Angiographic/device success (%) (Angiographic device success is determined by confirming the accurate placement of the device within the targeted coronary arteries through X-ray examination.)
- Procedural success (%) (Procedural success is determined by successful implantation of the stent and clearance of blockage.)
- Clinically justified Target Lesion Revascularization (TLR) (%) at 12 months
The following secondary safety endpoints were assessed:
- MACE (%) until 12 months (Clinically Justified)
- Device-related SAEs until 12 months (Clinically Justified)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Drug Eluting Coronary StentIts a single arm multicenter registry to investigate safety and efficacy of product by clinical follow up at one month and 12 month |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug Eluting Coronary StentThe Drug Eluting Coronary stent is indicated for the treatment of de novo coronary artery lesions in patients with symptomatic ischemic heart disease. | Device | Single Arm |
Primary outcome
888 Number of Participants With Major Adverse Cardiac Events (MACE) at 30 Days
Time frame: 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.
1 secondary outcome
• MACE (%) Until 12 Months • Device-related SAEs Until 12 Months
Time frame: 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Study Protocol and Results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhavin Oza, Bsc study chair
Frisch Medical Devices
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug Eluting Coronary Stent in people with Coronary Arterial Disease (CAD), run by Frisch Medical Device Private Limited at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India, Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
888 Number of Participants With Major Adverse Cardiac Events (MACE) at 30 Days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.