Thousands enrolled in supraflex stent registry for coronary artery disease
NCT ID NCT03443999
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This registry is tracking 10,000 patients with coronary artery disease who receive the Supraflex sirolimus-eluting stent during routine care. The goal is to see how well the stent works in everyday practice, measuring outcomes like heart-related death, heart attacks, and the need for repeat procedures. Participants will be followed for up to five years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Supraflex Family Sirolimus-eluting Coronary Stent System
- What this could lead to
- If successful, this could confirm that the Supraflex stent is safe and effective for routine use in a wide range of patients with blocked heart arteries.
- What could go wrong
- This is an observational registry, not a randomized trial, so results may be influenced by patient selection. Stent procedures carry risks like blood clots or re-narrowing of arteries.
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
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About 10,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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.
Who is studied
Real-world patient population assigned for PCI who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Supraflex Family sirolimus-eluting stent.
- 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: 1. Age ≥ 18 years 2. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form 3. Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care. 4. The patient is willing and able to cooperate with study procedures and required follow up visits Exclusion Criteria: 1. Women with known pregnancy or who are lactating 2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) 3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements 4. Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Albert Schweitzer Ziekenhuis
RECRUITINGDordrecht, South Holland, Post bus 444 3300 AK, Netherlands
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Amphia Ziekenhuis
RECRUITINGBreda, North Brabant, 4818 CK Breda, Netherlands
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Catharina Ziekenhuis
RECRUITINGEindhoven, North Brabant, 5623 EJ, Netherlands
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Maasstad Ziekenhuis
RECRUITINGRotterdam, South Holland, 3079 DZ, Netherlands
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Medical Center Leeuwarden
RECRUITINGLeeuwarden, Provincie Friesland, 8934 AD, Netherlands
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Tergooi Ziekenhuis
RECRUITINGBlaricum, North Holland, 1261 AN, Netherlands
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ZorgSaam Hospital
RECRUITINGTerneuzen, Zeeuws- Vlaanderen, 4535 PA, Netherlands
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