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

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

Overview

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.

Primary outcome measures

• Target Lesion Failure (TLF) [Time frame: From enrollment to 1 year, 2 years and 3 years]

Secondary outcome measures (5)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 1 center

• Hospital Álvaro Cunqueiro — Vigo

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 S PMID 30170854
• 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

Identifiers

NCT: NCT07444957 · CAR-HAC-303

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗