Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease (SECuRE)

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.

Study Overview

• Status: Recruiting
• Conditions: ST-Elevation Myocardial Infarction; Drug Coated Balloon; Silent Ischemia; Coronary Arterial Disease (CAD); Stable Angina, Unstable Angina, NSTEMI; NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)

• Study Type: Observational
• Enrollment (Estimated): 1118

Contacts and Locations

• Study Contact: Name: Víctor A Jiménez Díaz, MD, MPH; Phone Number: +34986825564; Email: victor.alfonso.jimenez.diaz@sergas.es
• Study Contact Backup: Name: Pablo Juan-Salvadores, Pharma, MPH, PhD; Phone Number: +34986825564; Email: pablo.juan@iisgaliciasur.es

Study Locations

• Spain
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Recruiting
      • Hospital Álvaro Cunqueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Drug-coated balloon; patients treated in routine clinical practice using the SeQuent® Sirolimus-Coated Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to 1 year, 2 years and 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Index procedure
Major Adverse Cardiovascular Events (MACE)	Composite of cardiovascular death, non-fatal myocardial infarction, or target lesion revascularization.	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.	From enrollment to 1 year, 2 years and 3 years

Collaborators and Investigators

• Sponsor: Fundación Interhospitalaria para la Investigación Cardiovascular FIC
• Investigators: Study Chair: Víctor A Jiménez Díaz, MD, MPH, Hospital Álvaro Cunqueiro, Vigo. SERGAS; Study Director: Pablo Juan-Salvadores, Pharma, MPH, PhD, Galicia Sur Health Research Institute (IIS Galicia Sur), Cardiovascular Research Group, Vigo, Spain.

Publications and helpful links

General 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.
• Jimenez 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): July 5, 2027
• Study Completion (Estimated): July 6, 2030

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: coronary arterial disease; TLR; MACE; TVR; drug coated ballloon
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Chest Pain; Angina Pectoris; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: CAR-HAC-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No