To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.
Prospective, multicenter, non-randomized study designed to enroll up to 60 subjects to evaluate the safety and effectiveness of the cobalt-chromium sirolimus eluting coronary stent ALEX in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
index angioplasty with ALEX stent implatation
Carint Scanmed Szpital Sw. Rafala
Krakow, Bochenka 12, Poland
Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii
Krakow, Kopernika 17, Poland
Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny
Ustroń, Sanatoryjna 7, Poland
Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, Szpitalna 13, Poland
Assessment of stent strut coverage and parameters of restenosis
Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 12 months follow-up after the baseline procedure in group of first 20 patients
Time frame: at 12 months follow-up
Assessment of stent strut coverage and parameters of restenosis
Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 6 months follow-up after the baseline procedure in group of second 20 patients
Time frame: at 6 months follow-up
Assessment of stent strut coverage and parameters of restenosis
Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) at 3 months follow-up after the baseline procedure in group of third 20 patients
Time frame: at 3 months follow-up
Procedural success
Procedural success during baseline PCI assessed in coronary angiography (QCA)
Time frame: during index hospitalization
Occurrence of stent thrombosis
Occurrence of stent thrombosis at 30 days follow-up
Time frame: at 30 days follow-up
Occurrence of stent thrombosis
Occurrence of stent thrombosis at 12 months follow-up
Time frame: at 12 months follow-up
Incidence of Major Adverse Cardiac Events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej
Warsaw, Woloska 137, Poland
Incidence of Major Adverse Cardiac Events (MACEs) at 30 days follow-up defined as death, myocardial infarction target lesion re-PTCA or target lesion bypass graft
Time frame: at 30 days follow-up
Incidence of Major Adverse Cardiac Events
Incidence of Major Adverse Cardiac Events (MACEs) at 12 months follow-up defined as death, myocardial infarction target lesion re-PTCA or target lesion bypass graft
Time frame: at 12 months follow-up