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

NCT07444957 | Recruiting DMC

• 1 other identifier: CAR-HAC-303
• Study Type: observational
• Target: 1,118
• Locations: 1 country
• Sites: 1

Brief 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. 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); Drug Coated Balloon; ST-Elevation Myocardial Infarction; Silent Ischemia; NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI); Stable Angina, Unstable Angina, NSTEMI

Keywords

coronary arterial disease; drug coated ballloon; TLR; TVR; MACE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cardiac death

  From enrollment to 1 year, 2 years and 3 years

• Ischemia-Driven Target Lesion Revascularization (TLR)

  From enrollment to 2 years and 3 years

• Immediate Angiographic Procedural Success

  Index procedure

• Major Adverse Cardiovascular Events (MACE)

  From enrollment to 1 year, 2 years and 3 years

• Bleeding Events

  From enrollment to 1 year, 2 years and 3 years

Study Arms (1)

Drug-coated balloon

patients treated in routine clinical practice using the SeQuent® Sirolimus-Coated Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fundación Interhospitalaria para la Investigación Cardiovascular FIC: lead

Study Sites (1)

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 30170854 BACKGROUND

• 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.

  PMID: 38042617 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Víctor A Jiménez Díaz, MD, MPH

  Hospital Álvaro Cunqueiro, Vigo. SERGAS

  STUDY CHAIR

• Pablo Juan-Salvadores, Pharma, MPH, PhD

  Galicia Sur Health Research Institute (IIS Galicia Sur), Cardiovascular Research Group, Vigo, Spain.

  STUDY DIRECTOR

Central Study Contacts

Víctor A Jiménez Díaz, MD, MPH

CONTACT

+34986825564; victor.alfonso.jimenez.diaz@sergas.es

Pablo Juan-Salvadores, Pharma, MPH, PhD

CONTACT

+34986825564; pablo.juan@iisgaliciasur.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 3, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): July 5, 2027
• Study Completion (Estimated): July 6, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

ES (1)