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Can a dissolving stent coating beat a permanent one for blocked arteries?

NCT ID NCT01516723

Disease control Sponsor: R&D Cardiologie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial compares two types of drug-eluting stents—tiny mesh tubes that prop open arteries—in people with completely blocked coronary arteries. One stent uses a coating that dissolves over time (bioresorbable polymer) to release the drug sirolimus, while the other has a permanent coating that releases everolimus. The goal is to see which stent better keeps the artery open and reduces the chance of re-narrowing, measured by how much the vessel narrows again at 9 months. Participants are adults with a blocked artery that has been successfully reopened, and the study randomly assigns them to receive one of the two stents.

What this could mean

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

Active substance
Two types of drug-eluting stents: a hybrid sirolimus-eluting stent with a bioresorbable polymer (ORSIRO) and an everolimus-eluting stent with a durable polymer (XIENCE PRIME), both used to reopen totally blocked coronary arteries.
What this could lead to
If the bioresorbable-polymer stent works as well or better, it could reduce the risk of late stent complications and improve long-term outcomes for people with completely blocked coronary arteries.
What could go wrong
This is a mid-sized trial, and the outcome is measured at 9 months—longer-term effects, such as very late stent thrombosis, may not be fully captured. Also, results may not apply to all patients with coronary artery disease.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

330 people

The number who actually took part.

Started

Feb 2012

Finished

Dec 2020

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.

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: * the estimated duration of the occlusion is at least 4 weeks. * signs of ischemia related to the occluded coronary artery. * successful recanalization of the occluded artery is achieved. * reference diameter is \> 2.5 mm. * written informed consent obtained. EXCLUSION CRITERIA: * primary or rescue PCI for acute myocardial infarction * the lesion could not be crossed. * lesions with complex anatomy making successful stent deployment unlikely. * the guide wire is not in the true lumen distal to the occlusion. * Sirolimus or zotarolimus allergy * venous or arterial bypass grafts * pregnant or nursing women. * participation in an other trial. * factors making long-term follow-up difficult or unlikely. * life expectancy \< 1 year. * contraindications for ASA or Clopidogrel or heparin. * use of coumadins that could not be stopped before the procedure.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Coronary Disease coronary stenosis

As listed by the trial registrant

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

Coronary artery disease Coronary disease Coronary stenosis

Contacts and locations

Locations

  • AMC

    Amsterdam, Amsterdam, 1105AZ, Netherlands

  • AZ Middelheim

    Antwerp, Antwerpen, 2020, Belgium

  • Catharina Ziekenhuis

    Eindhoven, Eindhoven, 5602ZA, Netherlands

  • St Antonius Hospital

    Nieuwegein, 3435CM, Netherlands

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