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Special stent fails to beat standard for tricky heart blockage

NCT ID NCT03508219

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new type of stent (BiOSS LIM C) designed for blockages at the left main coronary artery fork. The trial enrolled 130 people with severe blockages. Unfortunately, the new stent did not work as well as the standard stent, and the study was stopped early.

What this could mean

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

Active substance
BiOSS LIM C stent (a drug-coated stent for bifurcation blockages)
What this could lead to
If it had succeeded, this could have pointed toward a better treatment for complex left main coronary blockages.
What could go wrong
The trial was terminated early because the new stent was not as effective as the standard stent. This is an early-stage device study with limited participants, so results may not apply broadly.

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

130 people

The number who actually took part.

Started

Aug 2018

Finished

Apr 2021

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 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: * Patient has distal unprotected Left-Main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥50% requiring revascularization. * Left-Main Medina classification 100, 110, 101, 011, 010, 111 * Clinical and anatomic eligibility for PCI as agreed by the local Heart Team including anatomic SYNTAX Score (\<33). * Distal left main reference vessel diameter ≥3.0 mm and ≤5.5 mm. All target lesions must be located in a native coronary artery. * Patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values * Able to understand and provide informed consent and comply with all study procedures including follow-up Exclusion Criteria: * Prior PCI of the left main bifurcation at any time prior to enrollment * Currently participating in another trial and not yet at its primary endpoint. * Prior PCI of any other (non left main bifurcation) coronary artery lesion within 6 months (\<6 months) prior to enrollment. * Left-Main Medina classification 001. * Any segment of the left main bifurcation (distal left main, ostial Left Anterior Descending Artery (LAD) or ostial Left Circumflex Artery (LCX) presenting with a chronic total occlusion, or containing a visible thrombus. * Excessive angulation of the left main bifurcation (i.e. an angulation \>90° between proximal LAD and proximal LCX) * Direct stenting of the left main bifurcation * Prior Coronary Artery Bypass Surgery (CABG) at any time prior to enrollment * Patient requiring or may require additional surgery (cardiac or non-cardiac) within one year * Ongoing myocardial infarction or recent myocardial infarction with cardiac biomarker levels still elevated. * Known renal insufficiency (e.g. serum creatinine \>2.5mg/dL, or creatinine clearance ≤30mL/min, or patient on dialysis). * Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor. * Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 12 months. * Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential). * Concurrent medical condition with a life expectancy of less than 12 months. * The patient is unwilling/not able to return for outpatient clinic at 12 month follow-up. * Currently participating in another trial and not yet at its primary endpoint.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Centre FRA-001

    Aix-en-Provence, France

  • Research Centre FRA-002

    Saint-Denis, France

  • Research Centre FRA-003

    Grenoble, France

  • Research Centre FRA-004

    Bron, France

  • Research Centre ITA-001

    Naples, Italy

  • Research Centre ITA-002

    Ragusa, Italy

  • Research Centre ITA-003

    Syracuse, Italy

  • Research Centre PL-001

    Warsaw, Poland

  • Research Centre PL-002

    Zabrze, Poland

  • Research Centre PL-003

    Zabrze, Poland

  • Research Centre PL-004

    Olsztyn, Poland

  • Research Centre PL-005

    Poznan, Poland

  • Research Centre PL-006

    Katowice, Poland

  • Research Centre PL-007

    Krakow, Poland

  • Research Centre PL-008

    Warsaw, Poland

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