Coronary Artery Disease Clinical Trial
— SCOREOfficial title:
PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease
The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
Status | Recruiting |
Enrollment | 1302 |
Est. completion date | December 31, 2025 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All common significant coronary lesions - Target lesion length >34mm need to be covered with at least 2 devices - Patients eligible for this study must be at least 18 years of age - The patient must fulfil the standard recommendations for percutaneous coronary intervention (PCI), based on the last ESC recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment Exclusion Criteria: - Intolerance to sirolimus - Allergy to components of the coating - Pregnancy and lactation - Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized - Cardiogenic shock - Risk of an intraluminal thrombus - Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy - Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior - Severe allergy to contrast media - Lesions which are untreatable with PCI or other interventional techniques - Patients with an ejection fraction of < 30 % - Vascular reference diameter < 2.00 mm - Treatment of the left stem (first section of the left coronary artery) - Indication for a bypass surgery - Contraindication for whichever accompanying medication is necessary |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Jena | Jena | Thüringen |
Lead Sponsor | Collaborator |
---|---|
B. Braun Melsungen AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target Lesion Failure (TLF) | Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR). | at 12 months | |
Secondary | Target Lesion Failure (TLF) | Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR). | at 24 months | |
Secondary | ischemia driven target lesion revascularization (TLR) | at 12 months | ||
Secondary | ischemia driven target lesion revascularization (TLR) | at 24 months | ||
Secondary | all-cause death, cardiac death | at 12 months | ||
Secondary | all-cause death, cardiac death | at 24 months | ||
Secondary | all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI) | at 12 months | ||
Secondary | all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI) | at 24 months | ||
Secondary | major adverse coronary event (MACE) | major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization | at 12 months | |
Secondary | major adverse coronary event (MACE) | major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization | at 24 months | |
Secondary | Dual Antiplatelet Therapy (DAPT) compliance | at 4 weeks | ||
Secondary | Dual Antiplatelet Therapy (DAPT) compliance | at 3 months | ||
Secondary | Probable or definite stent-thrombosis of In-stent treated lesions | accumulated at 12 months | ||
Secondary | Probable or definite stent-thrombosis of In-stent treated lesions | accumulated at 24 months | ||
Secondary | Procedural success | final diameter stenosis < 30 % without flow-limiting dissections | immediately after procedure | |
Secondary | Bleeding complications according to the Bleeding Academic Research Consortium (BARC) | accumulated at 3 months | ||
Secondary | Bleeding complications according to the Bleeding Academic Research Consortium (BARC) | accumulated at 12 months | ||
Secondary | Bleeding complications according to the Bleeding Academic Research Consortium (BARC) | accumulated at 24 months |
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