The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The objective is to determine the success of the procedure and the preservation of vascular permeability.
The preset registry aim is to evaluate the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The principal objective is to determine the success of the procedure and the preservation of vascular permeability.
Study Type
OBSERVATIONAL
Enrollment
1,000
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGTarget Lesion Revascularization (TLR) with clinical follow-up at 12 months.
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
Time frame: From baseline to 12 months
Success of balloon dilation.
Success of balloon dilation.
Time frame: Baseline
Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.
MACE rate and MACE rate accumulated at 12 months.
Time frame: From baseline to 12 months
Premature follow-up indication
Premature follow-up indication
Time frame: From baseline to 12 months
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