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New heart stent shows promise in 888-Patient trial

NCT ID NCT06769217

Disease control Sponsor: Frisch Medical Device Private Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug-coated stent called EvroSure in 888 people with blocked heart arteries. The stent releases medicine to keep the artery open and prevent future blockages. Researchers tracked major heart events like heart attacks or the need for repeat procedures at 30 days and 12 months to see if the stent is safe and works well.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

888 people

The number who actually took part.

Started

Jan 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The patient must be ≥ 18 years of age; 2. Patient was an acceptable candidate for PTCA, Stenting, or Emergent CABG; 3. Patient has clinical evidence of ischemic heart disease or a positive functional study 4. Patient and his or her treating physician agree that the patient will comply with all the required post-procedure follow-up. 5. Target lesion(s) present with ≥50% stenosis, in one or more vessels 6. Target lesions have to be de novo; 7. One or more target lesions require treatment 8. Reference vessel diameter of target lesion(s) must be ≥ 2.25mm and ≤ 4.5mm, by visual estimate Exclusion Criteria: 1. Previous PTCA with any stent 2. History of CVA or TIA within the last 3 months 3. Patient has active infection 4. Concurrent medical condition with a life expectancy of less than 12 months 5. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, or ticlopidine including thrombocytopenia, neutropenia, or leukopenia 6. Active peptic ulcer or upper gastrointestinal bleeding. 7. Current participation in an investigational drug or device trial that has not completed its primary endpoint follow-up period. 8. Pregnancy or woman of childbearing potential who, in the opinion of the investigator, does not take adequate measures to prevent conception. 9. Known hypersensitivity or contraindication to cobalt, chromium, or nickel

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary arterial disease (CAD)

Contacts and locations

Locations

  • Baroda Heart Institute & Research Centre

    Vadodara, Gujarat, 390007, India

  • Grandmed Lubuk Pakam Hospita

    Tanjung Morawa, North Sumatra, Indonesia

  • Hospital (P) Ltd.

    Kozhikode, Kerala, 673002, India

  • Medical College & Hospital

    Bangalore, Karnataka, India

  • Primaya Tangerang

    Jakarta, Indonesia

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