An observational study in Coronary Arterial Disease (CAD), NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI) and Stable Angina, Unstable Angina, NSTEMI, sponsored by Fundación Interhospitalaria para la Investigación Cardiovascular FIC. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Fundación Interhospitalaria para la Investigación Cardiovascular FIC · Observational
This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled.
The primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups.
The study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 1,118 is above the median of 508 across 103 observational studies indexed under Angina, Stable.
Browse Angina, Stable studies →This is the only study on the registry with Fundación Interhospitalaria para la Investigación Cardiovascular FIC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years) with coronary artery disease undergoing percutaneous coronary intervention in routine clinical practice, in whom treatment of a coronary stenosis in a native vessel (de novo lesion or in-stent restenosis) or in a coronary bypass graft with the SeQuent® Sirolimus-Coated Balloon is selected at the operator's discretion. Consecutive, unselected "real-world" patients will be enrolled across participating centers, including a broad range of clinical presentations and anatomical lesion substrates, provided they meet the study eligibility criteria and provide written informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Angiographic exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients treated in routine clinical practice using the SeQuent® Sirolimus-Coated Balloon
Target Lesion Failure (TLF)
Target lesion failure is defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR), assessed following treatment with the SeQuent® Sirolimus-Coated Balloon in routine clinical practice.
Time frame: From enrollment to 1 year, 2 years and 3 years
Cardiac death
Cardiac death is defined as any death resulting from an immediate cardiac cause, procedure-related cardiac complications, or any death of unknown cause.
Time frame: From enrollment to 1 year, 2 years and 3 years
Ischemia-Driven Target Lesion Revascularization (TLR)
Incidence of ischemia-driven target lesion revascularization following treatment with the SeQuent® Sirolimus-Coated Balloon.
Time frame: From enrollment to 2 years and 3 years
Immediate Angiographic Procedural Success
Procedural success defined as residual stenosis ≤30% and absence of flow-limiting dissection (TIMI flow \<3) immediately after the intervention.
Time frame: Index procedure
Major Adverse Cardiovascular Events (MACE)
Composite of cardiovascular death, non-fatal myocardial infarction, or target lesion revascularization.
Time frame: From enrollment to 1 year, 2 years and 3 years
Bleeding Events
Incidence of bleeding events assessed according to Bleeding Academic Research Consortium (BARC) criteria.
Time frame: From enrollment to 1 year, 2 years and 3 years
Plan to share: Undecided — Individual participant data sharing has not been planned. Data access is restricted due to confidentiality agreements, ethical approvals, and data protection regulations. Any future data sharing would require additional approvals and appropriate data anonymization.
Started Jan 2026 (actual). Primary completion is estimated for Jul 2027, 18 months after the start.
Of 52 observational studies under Angina, Stable, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
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