New heart stent under Real-World watch: will it hold up?
NCT ID NCT04899141
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is tracking 400 people with coronary artery disease who received the ihtDEStiny drug-eluting stent during a routine procedure to open blocked heart arteries. Researchers are monitoring how well the stent works over time, including rates of heart attacks, repeat procedures, and deaths. The goal is to see if this stent performs safely in everyday medical practice.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ihtDEStiny sirolimus-eluting coronary stent
- What this could lead to
- If successful, this registry could confirm that the ihtDEStiny stent is safe and effective for routine use in opening blocked heart arteries.
- What could go wrong
- This is an observational registry, not a randomized trial, so it cannot prove the stent is better than other stents. Results may not apply to all patients.
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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400 people
The number who actually took part.
- Started
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Oct 2021
- Expected to finish
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May 2028
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.
Who is studied
Patients with all inclusion criteria
- 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: * ≥18 years old * PCI and stent implantation indication according to ESC Myocardial Revascularization Guidelines * 1 or more stenosis at native coronary anatomy, in a 2-4mm vessel size, where 1 or more ihtDEStiny® drug eluting stent were implanted (or attempted to be implanted). * Informed consent signed after PCI Exclusion Criteria: * Patient refusal to participate in the study * Pregnancy * Other DES implantation during index PCI, or 30 days before of after index PCI * PCI at surgical grafts * PCI for in-stent restenosis * Killip class 3-4 Acute Coronary Syndromes (ACS) * High bleeding risk with dual antiplatelet intolerance for at least 3 months (or 6 months for ACS PCI) * Allergy or hypersensitivity to sirolimus * Patients requiring surgery (cardiac or non-cardiac) in the next 3 months after index PCI * Patients with life expectancy \<2 years * Patients included in other trials or clinical studies
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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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Centro Hospitalar Universitario Do Algarbe
Faro, 8000-386, Portugal
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Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
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Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, 15706, Spain
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Hospital General Universitario de Ciudad Real
Ciudad Real, 13005, Spain
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Hospital General Universitario de Elche
Elche, 03203, Spain
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Hospital San Pedro de Alcantara
Cáceres, 10003, Spain
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Hospital Universitari Arnau de Vilanova de Lleida
Lleida, 25198, Spain
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Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
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Hospital Universitario Donostia
Donostia / San Sebastian, 20014, Spain
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Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
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Hospital Universitario Lucus Agusti
Lugo, 27003, Spain
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Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
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Hospital Universitario Regional de Malaga Carlos Haya
Málaga, Malaga, 29010, Spain
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Hospital Universitario Virgen Arrixaca
Murcia, 30120, Spain
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Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
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Hospital Universitario de Araba
Vitoria-Gasteiz, 01009, Spain
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Hospital Universitario de Cruces
Barakaldo, 48903, Spain
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Hospital de Galdakao
Galdakao, 48960, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can heart stent patients go home in 6 hours?
- Can AI read heart scans to predict the next heart attack?
- Can a new drug cool the hidden inflammation that fuels heart disease?
- New CT scanner aims to cut unnecessary heart procedures
- Heart bypass surgeons test which vein layout keeps grafts open
- A soft patch that watches your heart beat in real time