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New stent study aims to improve heart outcomes for all, especially diabetics

NCT ID NCT04475380

Disease control Sponsor: Foundation of Cardiovascular Research and Education Enschede 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how well the Xience Sierra drug-coated stent works in a broad group of heart disease patients, including those with diabetes or prediabetes. Over 1,700 participants received the stent during a routine procedure to open blocked arteries. Researchers tracked heart-related events like death, heart attack, or need for repeat procedures for up to two years to see if the stent is safe and effective in real-world, high-risk patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xience Sierra everolimus-eluting stent
What this could lead to
If successful, this could confirm that the Xience Sierra stent is safe and effective for a wide range of heart disease patients, including those with diabetes.
What could go wrong
This is a completed observational study, not a randomized trial, so results may not prove superiority over other stents. Risks include typical stent complications like blood clots or re-narrowing.

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

1,757 people

The number who actually took part.

Started

Sep 2018

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

All-comers. Patients for elective PCI or acute PCI

Ages

18 years and older

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: * \>18 years * requiring PCI and treated with Xience Sierra * capable of providing informed consent Exclusion Criteria: * known intolerance to components of the study DES or antithrombotic/anticoagulant therapy * planned elective surgery necessitating interruption of dual antiplatelet therapy (DAPT) \< 3 months * patient is known to be pregnant, unlikely to adhere to follow-up or expected live \< 1 year

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome Angina Pectoris coronary artery disorder coronary restenosis coronary stenosis diabetes mellitus intermediate coronary syndrome myocardial infarction prediabetes syndrome

As listed by the trial registrant

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

Acute coronary syndrome Angina pectoris Angina, unstable Coronary artery disease Coronary restenosis Coronary stenosis Myocardial infarction

Contacts and locations

Locations

  • Haga Ziekenhuis

    The Hague, Netherlands

  • Thoraxcentrum Twente

    Enschede, Netherlands

More trials for these conditions

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