Heart stent showdown: which device works best for blocked arteries?
NCT ID NCT04390672
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of stents (small mesh tubes) used to open blocked heart arteries in people with severe three-vessel coronary artery disease. About 1,550 participants will receive either the SUPRAFLEX Cruz or SYNERGY stent. The goal is to see which stent is safer and more effective at preventing death, stroke, heart attack, or the need for repeat procedures over one year.
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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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About 1,550 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients' ≥18 years. 2. At least 1 stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, LCX and/or side branch, RCA and/or side branch) supplying viable myocardium without left main involvement. 3. The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.50 mm (no limitation on the number of treated lesions, vessels, or lesion length). 4. Patients with chronic coronary syndrome or stabilized acute coronary syndromes. 5. All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II, provided that the SYNTAX Score II recommends equipoise risk (PCI or CABG) or PCI only. 6. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required evaluations. 7. Agree with conditional longer follow up from 2 to 5 years with one phone contact yearly. Exclusion Criteria: 1. Under the age of 18. 2. Unable to give informed consent. 3. 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 according to local practice). 4. Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor. 5. Prior PCI or prior CABG. 6. Ongoing ST-elevation myocardial infarction (STEMI). 7. Cardiogenic shock is also an exclusion criteria. 8. Concurrent medical condition with a life expectancy of less than 2 years. 9. Currently participating in another trial and not yet at its primary endpoint. 10. Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis. 11. Previous intracranial haemorrhage.
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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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NUIG
Galway, H91 TK33, Ireland
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Other studies related to the condition(s) this trial covers.
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