Coronary Arterial Disease (CAD)SECuRENCT07444957
Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease
An observational study of Coronary Arterial Disease (CAD) and NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI), run by Fundación Interhospitalaria para la Investigación Cardiovascular FIC at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI), Stable Angina, Unstable Angina, NSTEMI
- How many people
- 1,118 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jan 2026to 6 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- All patients must provide written informed consent.
- Patients aged ≥18 years with coronary artery disease in whom, at the operator's discretion, treatment of a coronary stenosis in a native vessel (either de novo lesion or in-stent restenosis) or in a coronary bypass graft using the cSCB is indicated, in accordance with routine clinical practice.
- All treated lesions/segments (single or tandem) must receive cSCB therapy covering at least 3 mm beyond both edges of the lesion or pre-dilated segment to avoid geographic miss.
- In patients with multivessel coronary artery disease, all non-target vessels will be treated according to operator discretion: a) If more than one vessel is treated with the investigational device (SeQuent® SCB), all vessels will be documented and analyzed separately. b) Only one lesion per vessel will be included unless lesions are separated by ≥20 mm. c) Only one lesion per vessel will be included. d) If more than one lesion in the target vessel requires treatment, all lesions treated with a device different from the investigational procedure or with a device other than the investigational device (SeQuent® SCB) must be separated from the target lesion by ≥20 mm or considered as a single treated lesion according to this study protocol.
Who cannot join
- Explicit refusal by the patient to participate in the study.
- Known intolerance to sirolimus or to any component of the investigational device.
- Contraindication to any antiplatelet therapy.
- Life expectancy less than 12 months.
- Indication for surgical coronary revascularization.
- Pregnancy or breastfeeding.
Show all 13Show fewer
- Clinical characteristics considered unsuitable for drug-coated balloon use at the operator's discretion, including: a) Hemorrhagic diathesis or other conditions such as gastrointestinal ulceration or cerebrovascular disorders restricting the use of antiplatelet therapy. b) Cardiogenic shock. c) Patients with left ventricular ejection fraction <30% without the use of a ventricular assist device during PCI.
- Angiographic exclusion criteria
- Reference vessel diameter <2.00 mm or >4.0 mm.
- Treatment of the left main coronary artery.
- Lesions not amenable to PCI or other interventional techniques.
- Coronary artery spasm in the absence of significant stenosis.
- Target lesion not suitable for drug-coated balloon-only PCI at the operator's discretion, including: a) Aorto-ostial lesions. b) Lesions with significant persistent residual thrombotic content visible in the vessel despite thromboaspiration. c) Treatment shortly after myocardial infarction with evidence of thrombus or impaired coronary flow.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312
About this study
Official title: Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study
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.
- Conditions
- Coronary Arterial Disease (CAD), NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI), Stable Angina, Unstable Angina, NSTEMI, Drug Coated Balloon, ST-Elevation Myocardial Infarction, Silent Ischemia
- Keywords
- coronary arterial disease, drug coated ballloon, TLR, TVR, MACE
- Medical subject headings
- Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon | patients treated in routine clinical practice using the SeQuent® Sirolimus-Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 1 year, 2 years and 3 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Index procedure
Major Adverse Cardiovascular Events (MACE)
Composite of cardiovascular death, non-fatal myocardial infarction, or target lesion revascularization.
Measured: 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.
Measured: From enrollment to 1 year, 2 years and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start5 Jan 2026
- Primary completion5 Jul 2027 (estimated)
- Study completion6 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Interhospitalaria para la Investigación Cardiovascular FIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Víctor A Jiménez Díaz, MD, MPH, Study chair, Hospital Álvaro Cunqueiro, Vigo. SERGASPablo Juan-Salvadores, Pharma, MPH, PhD, Study director, Galicia Sur Health Research Institute (IIS Galicia Sur), Cardiovascular Research Group, Vigo, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444957
- Sponsor's protocol ID
- CAR-HAC-303
- Acronym
- SECuRE
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
PubMed 30170854Jimenez Diaz VA, Iniguez Romo A. Intracoronary artery visualisation of crystalline sirolimus deposits after drug-coated balloon angioplasty for acute coronary syndrome. Lancet. 2023 Dec 2;402(10417):2111-2112. doi: 10.1016/S0140-6736(23)02349-8. No abstract available.
PubMed 38042617
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07444957
- Acronym / sponsor ID
- SECuRE / CAR-HAC-303
- Conditions
- Coronary Arterial Disease (CAD), NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI), Stable Angina, Unstable Angina, NSTEMI, Drug Coated Balloon, ST-Elevation Myocardial Infarction, Silent Ischemia
- Keywords
- coronary arterial disease, drug coated ballloon, TLR, TVR, MACE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,118 participants (estimated)
- Lead sponsor
- Fundación Interhospitalaria para la Investigación Cardiovascular FICUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Jul 2027 (estimated)
- Study completion
- 6 Jul 2030 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon | – | –patients treated in routine clinical practice using the SeQuent® Sirolimus-Coated Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- All patients must provide written informed consent.
- Patients aged ≥18 years with coronary artery disease in whom, at the operator's discretion, treatment of a coronary stenosis in a native vessel (either de novo lesion or in-stent restenosis) or in a coronary bypass graft using the cSCB is indicated, in accordance with routine clinical practice.
- All treated lesions/segments (single or tandem) must receive cSCB therapy covering at least 3 mm beyond both edges of the lesion or pre-dilated segment to avoid geographic miss.
- In patients with multivessel coronary artery disease, all non-target vessels will be treated according to operator discretion: a) If more than one vessel is treated with the investigational device (SeQuent® SCB), all vessels will be documented and analyzed separately. b) Only one lesion per vessel will be included unless lesions are separated by ≥20 mm. c) Only one lesion per vessel will be included. d) If more than one lesion in the target vessel requires treatment, all lesions treated with a device different from the investigational procedure or with a device other than the investigational device (SeQuent® SCB) must be separated from the target lesion by ≥20 mm or considered as a single treated lesion according to this study protocol.
Key exclusion criteria (13 listed)
- Explicit refusal by the patient to participate in the study.
- Known intolerance to sirolimus or to any component of the investigational device.
- Contraindication to any antiplatelet therapy.
- Life expectancy less than 12 months.
- Indication for surgical coronary revascularization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target Lesion Failure (TLF)
Time frame: From enrollment to 1 year, 2 years and 3 years
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.
5 secondary outcomes
Cardiac death
Time frame: From enrollment to 1 year, 2 years and 3 years
Ischemia-Driven Target Lesion Revascularization (TLR)
Time frame: From enrollment to 2 years and 3 years
Immediate Angiographic Procedural Success
Time frame: Index procedure
Major Adverse Cardiovascular Events (MACE)
Time frame: From enrollment to 1 year, 2 years and 3 years
Bleeding Events
Time frame: From enrollment to 1 year, 2 years and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 30170854Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
- Background: PubMed 38042617Jimenez Diaz VA, Iniguez Romo A. Intracoronary artery visualisation of crystalline sirolimus deposits after drug-coated balloon angioplasty for acute coronary syndrome. Lancet. 2023 Dec 2;402(10417):2111-2112. doi: 10.1016/S0140-6736(23)02349-8. No abstract available.
- Individual participant dataSharing planned: 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.
Related trials for Coronary Arterial Disease (CAD)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Víctor A Jiménez Díaz, MD, MPH study chair
Hospital Álvaro Cunqueiro, Vigo. SERGAS
Pablo Juan-Salvadores, Pharma, MPH, PhD study director
Galicia Sur Health Research Institute (IIS Galicia Sur), Cardiovascular Research Group, Vigo, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI), run by Fundación Interhospitalaria para la Investigación Cardiovascular FIC at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Víctor A Jiménez Díaz, MD, MPH (+34986825564, victor.alfonso.jimenez.diaz@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: From enrollment to 1 year, 2 years and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07444957, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.