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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).
The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical data) with 80% power. Primary and secondary outcome variables are international accepted parameters in stent-trials, which sufficiently describe the efficacy and safety of the investigated device and allow clinical conclusions. Additional attention will be paid to those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT).
The aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4 mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion is longer than 34 mm, more than one stent needs to be used.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeQuent® SCB drug-coated balloon catheter | Device | treatment of coronary artery disease with SeQuent® SCB of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| ischemia driven target lesion revascularization (TLR) |
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Inclusion Criteria:
Exclusion Criteria:
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This is a single-armed, prospective, international, multi-center, post-market study in patients with coronary artery disease and indication for PCI either due to anginal symptoms and a relevant stenotic coronary lesion during angiography or due to documented ischemia by non-invasive or invasive functional testing.
All patients who undergo a target intervention with the SCB will be followed for 12 and 24 months after initial PCI.
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia Otto, MD | Universitätsklinikum Jena - Klinik für Innere Medizin I | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37003986 | Derived | Otto S, Diaz VAJ, Weilenmann D, Cuculi F, Nuruddin AA, Leibundgut G, Alfonso F, Wan Ahmad WA, Pyxaras S, Rittger H, Steen P, Gaede L, Schulze C, Wohrle J, Rosenberg M, Waliszewski MW. Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial. BMC Cardiovasc Disord. 2023 Mar 31;23(1):176. doi: 10.1186/s12872-023-03187-x. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| at 12 months |
| ischemia driven target lesion revascularization (TLR) | at 24 months |
| all-cause death, cardiac death | at 12 months |
| all-cause death, cardiac death | at 24 months |
| all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI) | at 12 months |
| all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI) | at 24 months |
| 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 |
| 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 |
| Dual Antiplatelet Therapy (DAPT) compliance | at 4 weeks |
| Dual Antiplatelet Therapy (DAPT) compliance | at 3 months |
| Probable or definite stent-thrombosis of In-stent treated lesions | accumulated at 12 months |
| Probable or definite stent-thrombosis of In-stent treated lesions | accumulated at 24 months |
| Procedural success | final diameter stenosis < 30 % without flow-limiting dissections | immediately after procedure |
| Bleeding complications according to the Bleeding Academic Research Consortium (BARC) | accumulated at 3 months |
| Bleeding complications according to the Bleeding Academic Research Consortium (BARC) | accumulated at 12 months |
| Bleeding complications according to the Bleeding Academic Research Consortium (BARC) | accumulated at 24 months |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |