Crystalline sirolimus-coated balloon for treating coronary artery disease

Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study

This tests whether a crystalline sirolimus-coated balloon is safe and effective for adults having percutaneous coronary intervention for coronary artery blockages or in-stent restenosis.

Quick facts

• Study type: Observational
• Enrollment: 1118 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación Interhospitalaria para la Investigación Cardiovascular FIC (other)
• Locations: 1 site (Vigo, Pontevedra)
• Trial ID: NCT07444957 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter post-market observational registry enrolling consecutive adults treated with the crystalline sirolimus-coated balloon (SeQuent® SCB) during routine PCI for de novo coronary lesions or in-stent restenosis. Lesions are treated per operator discretion with the device covering at least 3 mm beyond both lesion edges, and patients are followed clinically with primary endpoint assessment at 12 months and extended follow-up to 36 months. The primary outcome is target lesion failure at 12 months, defined as target vessel myocardial infarction or ischemia-driven target lesion revascularization, and secondary outcomes include procedural success, MACE, bleeding, and subgroup analyses. No investigational randomization is performed because this is an observational post-market evaluation of real-world use.

Who should consider this trial

Good fit: Adults aged 18 or older with coronary artery disease who are undergoing PCI for a native vessel de novo lesion or in-stent restenosis and for whom the operator plans to use the SeQuent® sirolimus-coated balloon are ideal candidates.

Not a fit: Patients with anatomy unsuitable for balloon-only therapy (for example heavy calcification, large thrombus burden, lesions requiring stent scaffolding, or vessels where the device cannot cover lesion edges) are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the device could lower the need for repeat procedures and reduce ischemic events after PCI while avoiding additional stent implantation.

How similar studies have performed: Drug-coated balloons have shown benefit in certain restenosis and small-vessel settings, and early data for sirolimus-coated balloons are promising though less extensive than for older paclitaxel-coated devices.

Eligibility criteria

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.

Where this trial is running

Vigo, Pontevedra

• Hospital Álvaro Cunqueiro — Vigo, Pontevedra, Spain (RECRUITING)

Study contacts

• Study coordinator: Víctor A Jiménez Díaz, MD, MPH

Conditions: Coronary Arterial Disease, NSTEMI - Non-ST Segment Elevation Myocardial Infarction, Stable Angina, Unstable Angina, NSTEMI, Drug Coated Balloon, ST-Elevation Myocardial Infarction, Silent Ischemia, coronary arterial disease, drug coated ballloon