The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.
The aim of this post market surveillance is to document the safety and efficacy of the drug-coated balloon Sequent® Please Neo in combination with the NSE Alpha scoring balloon in the treatment of both in-stent restenosis and de-novo lesions in native coronary arteries with reference diameters of 2.5 mm up to 4.0 mm with lesion lengths of 30 mm for procedural success and preservation of vessel patency
Study Type
OBSERVATIONAL
Enrollment
481
Percutaneous Coronary Intervention
Klinikum Ernst von Bergmann
Potsdam, Germany
Target Vessel Failure
Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death
Time frame: 9 months
procedural success rate
lesion crossing success in in-stent restenotic lesions
Time frame: intraprocedural
Target Lesion Revascularization rate = Re-PCI + CABG(TLR)
Time frame: 9 months
cardiac death
death of cardiac or unknown causes
Time frame: 9 months
Rate of coronary arterial bypass grafting (CABG)
Time frame: 9 months
rate of myocardial infarction
Time frame: 9 months
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