Coronary Artery Disease
Conditions
Brief summary
The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.
Interventions
DEVICECoroflex Blue (BMS) followed by SeQuent Please (DEB)
* standard techniques will be used * maximal vasodilatation after nitro application * baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap) * 6 French guiding catheter at least * target lesion will be crossed with standard guidewire * direct stenting at the discretion of the investigator * if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted) * full lesion coverage will be ensured (with one or more stents) * only insert assigned stent type * BMS needs to be fully embedded in vessel wall * post-dilation with high pressure is required before treatment with DEB * DEB will be inflated with nominal pressure (balloon equates to vessel diameter) * length of DEB should exceed the BMS by 2-3 mm on each side * if dissection, full length of dissection and optional additional stented area should be treated with additional DEB (to avoid geographic miss)
DEVICECoroflex Please (DES)
* standard techniques will be used * maximal vasodilatation after nitro application * baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap) * 6 French guiding catheter at least * target lesion will be crossed with standard guidewire * direct stenting at the discretion of the investigator * if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted) * full lesion coverage will be ensured (with one or more stents) * only insert assigned stent type
Sponsors
Aesculap AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia * Presence of one or more coronary artery stenosis \>50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent * One lesion treated with the study device
Exclusion criteria
* Pregnancy * Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material * Inability to provide informed consent * Currently participating in another trial before reaching the primary endpoint * Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period * Acute or recent myocardial infarction * left ventricular ejection fraction (LVEF) \< 30 % * Stroke or transient ischemic attack within 6 months * Stented segment longer than 23 mm * Vessel diameter of less than 2,5 mm * Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events (MACE) - target vessel failure (TVF) | 9 months | consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| in-stent binary restenosis | 9 months | defined as \>= 50 % diameter stenosis (% DS) |
| Angiographic and clinical stent thrombosis | 30 days | — |
| Major adverse cardiac events (MACE) | 1 year | defined as the composite of cardiovascular death, stroke, myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR), as well as the individual components of target vessel revascularization (TVR) and Major adverse cardiac events (MACE) and stent thrombosis |
| In-segment percent diameter stenosis (%DS) | 9 months | — |
| In-stent and in-segment late luminal loss | 9 months | — |
| In-stent and in-segment minimal luminal diameter (MLD) | 9 months | — |
Countries
Poland
Outcome results
None listed