Coronary Arterial Disease (CAD), Drug Coated Balloon, NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI), Silent Ischemia, Stable Angina, Unstable Angina, NSTEMI, ST-Elevation Myocardial Infarction
Conditions
Keywords
coronary arterial disease, drug coated ballloon, TLR, TVR, MACE
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.
Interventions
None listed
Sponsors
Fundación Interhospitalaria para la Investigación Cardiovascular FIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | From enrollment to 1 year, 2 years and 3 years | Cardiac death is defined as any death resulting from an immediate cardiac cause, procedure-related cardiac complications, or any death of unknown cause. |
| Ischemia-Driven Target Lesion Revascularization (TLR) | From enrollment to 2 years and 3 years | Incidence of ischemia-driven target lesion revascularization following treatment with the SeQuent® Sirolimus-Coated Balloon. |
| Immediate Angiographic Procedural Success | Index procedure | Procedural success defined as residual stenosis ≤30% and absence of flow-limiting dissection (TIMI flow \<3) immediately after the intervention. |
| Major Adverse Cardiovascular Events (MACE) | From enrollment to 1 year, 2 years and 3 years | Composite of cardiovascular death, non-fatal myocardial infarction, or target lesion revascularization. |
| Bleeding Events | From enrollment to 1 year, 2 years and 3 years | Incidence of bleeding events assessed according to Bleeding Academic Research Consortium (BARC) criteria. |
Countries
Spain
Contacts
CONTACTVíctor A Jiménez Díaz, MD, MPH
CONTACTPablo Juan-Salvadores, Pharma, MPH, PhD
STUDY_CHAIRVíctor A Jiménez Díaz, MD, MPH
Hospital Álvaro Cunqueiro, Vigo. SERGAS
STUDY_DIRECTORPablo Juan-Salvadores, Pharma, MPH, PhD
Galicia Sur Health Research Institute (IIS Galicia Sur), Cardiovascular Research Group, Vigo, Spain.
Outcome results
None listed