Special stent fails to beat standard for tricky heart blockage
NCT ID NCT03508219
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
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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
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130 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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Apr 2021
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Research Centre FRA-001
Aix-en-Provence, France
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Research Centre FRA-002
Saint-Denis, France
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Research Centre FRA-003
Grenoble, France
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Research Centre FRA-004
Bron, France
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Research Centre ITA-001
Naples, Italy
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Research Centre ITA-002
Ragusa, Italy
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Research Centre ITA-003
Syracuse, Italy
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Research Centre PL-001
Warsaw, Poland
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Research Centre PL-002
Zabrze, Poland
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Research Centre PL-003
Zabrze, Poland
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Research Centre PL-004
Olsztyn, Poland
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Research Centre PL-005
Poznan, Poland
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Research Centre PL-006
Katowice, Poland
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Research Centre PL-007
Krakow, Poland
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Research Centre PL-008
Warsaw, Poland
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