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Heart stent study shows promise for blocked arteries

NCT ID NCT03809715

Disease control Sponsor: B. Braun Melsungen AG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at a device called Coroflex ISAR Neo, a stent used to open blocked heart arteries. Researchers wanted to see if it was safe and worked well. Over 3,500 people with coronary artery disease took part. The main goal was to see how many needed a repeat procedure within a year.

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.

Participants

3,520 people

The number who actually took part.

Started

Jan 2019

Finished

Aug 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.

Who is studied

The investigator of each study site has the responsibility of screening all potential patients and selecting those who fulfil the inclusion criteria of this study protocol. Therefore, at each site a study with similar inclusion criteria cannot be conducted while the recruitment of this study is in progress. Screening will be performed during the physical examination to verify the "patient related enrolment criteria". The second part of the screening procedure will be completed during the diagnostic angiography to verify that the target lesion fulfils all "lesion related enrolment criteria".

Ages

18 years and older

Sex

Anyone

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: Coroflex® ISAR NEO is intended to be used for * All common significant coronary lesions * Target lesion length \>34mm need to be covered with at least 2 stents * Patients eligible for this study must be at least 18 years of age. * The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment. Exclusion Criteria: * Intolerance to sirolimus and/or probucol * Allergy to components of the coating * Pregnancy and lactation * Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized * Cardiogenic shock * Risk of an intraluminal thrombus * Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy * Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior * Severe allergy to contrast media * Lesions which are untreatable with PCI or other interventional techniques * Patients with an ejection fraction of \< 30 % * Vascular reference diameter \< 2.00 mm * Treatment of the left stem (first section of the left coronary artery) * Indication for a bypass surgery * Contraindication for whichever accompanying medication is necessary

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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 artery disease

Contacts and locations

Locations

  • Clinique St. Hilaire

    Rouen, 76000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.