multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology.
The primary objectives are: 1. To analyze the trends of IVL use overall and according to clinical/anatomical indications 2. To evaluate the rates of procedural success, defined as success in facilitating stent delivery with \<30% residual stenosis and without in-hospital 3. To describe the cumulative hierarchical incidence of MACE defined as: cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure The secondary objectives are: 1. To describe the rate of MACE at 3-, 6- and 12-months following the index procedure 2. To assess the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure 3. To describe the rates of target lesion failure (TLF) (see end-points definitions section) 4. To describe the rates of device crossing success (see end-points definitions section) 5. To describe the rates of serious angiographic complications (see end-points definitions section) 6. To assess predictors of clinical outcomes based on patient and procedural characteristics 7. To analyze current standards of practice regarding IVL technology in a real-world multinational cohort (technique, training, local protocols).
Study Type
OBSERVATIONAL
Enrollment
1,000
Use of IVL for the treatment of calcific coronary artery lesions at operator's discretion
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Red Cross Hospital
Athens, Greece
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
procedural success
success in facilitating stent delivery with \<30% residual stenosis and without in-hospital MACE
Time frame: Periprocedurally and from hospital admission to discharge (an average of 2 days)
cumulative hierarchical incidence of MACE
cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure
Time frame: At 30 days follow-up
rate of MACE at 3 months
rate of MACE at 3-months following the index procedure
Time frame: At 3 months follow-up
rate of MACE at 6 months
rate of MACE at 6-months following the index procedure
Time frame: At 6 months follow-up
rate of MACE at 12 months
rate of MACE at 12-months following the index procedure
Time frame: At 12 months follow-up
the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis
at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure
Time frame: 30-days, 3-, 6- and 12-months
the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Medisch Centrum Leeuwaarden
Leeuwarden, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
at any time point, any type of angina at 30-days follow-up
Time frame: at 30-days follow-up
the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis
at any time point, any type of angina at 3 months follow-up
Time frame: at 3 months follow-up
the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis
at any time point, any type of angina at 6 months follow-up
Time frame: at 6 months follow-up
the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis
at any time point, any type of angina at 12-months follow-up
Time frame: at 12-months follow-up