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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
202
* 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)
* 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
Upper Silesian Heart Center
Katowice, Poland
Major adverse cardiac events (MACE) - target vessel failure (TVF)
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
Time frame: 9 months
Major adverse cardiac events (MACE)
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
Time frame: 1 year
in-stent binary restenosis
defined as \>= 50 % diameter stenosis (% DS)
Time frame: 9 months
Angiographic and clinical stent thrombosis
Time frame: 30 days
Angiographic and clinical stent thrombosis
Time frame: 6 months
Angiographic and clinical stent thrombosis
Time frame: 9 months
Angiographic and clinical stent thrombosis
Time frame: 1 year
Angiographic and clinical stent thrombosis
Time frame: 2 years
Angiographic and clinical stent thrombosis
Time frame: 3 years
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In-stent and in-segment minimal luminal diameter (MLD)
Time frame: 9 months
In-segment percent diameter stenosis (%DS)
Time frame: 9 months
In-stent and in-segment late luminal loss
Time frame: 9 months