Prospective Registry on Intravascular Lithotripsy
NCT Number: NCT06577038
Acronym: BENELUX-IVL
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Calcific Coronary Arteriosclerosis
Interventions: DEVICE: PCI with use of IVL
Sponsor: Leiden University Medical Center
Collaborators: Shockwave Medical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-05-01
Completion Date: 2029-05-01
Locations: Cliniques Universitaires Saint-Luc, Brussel, Belgium|Red Cross Hospital, Athens, Greece|Amsterdam University Medical Center, Amsterdam, Noord Holland, Netherlands|Leiden University Medical Center, Leiden, Zuid Holland, 2333ZA, Netherlands|Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands|Rijnstate Ziekenhuis, Arnhem, Netherlands|Medisch Centrum Leeuwaarden, Leeuwarden, Netherlands|Radboud University Medical Center, Nijmegen, Netherlands

Summary:
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.

Primary Outcome Measures: procedural success, success in facilitating stent delivery with \<30% residual stenosis and without in-hospital MACE, 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, At 30 days follow-up
Secondary Outcome Measures: rate of MACE at 3 months, rate of MACE at 3-months following the index procedure, At 3 months follow-up|rate of MACE at 6 months, rate of MACE at 6-months following the index procedure, At 6 months follow-up|rate of MACE at 12 months, rate of MACE at 12-months following the index procedure, 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, 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, at any time point, any type of angina at 30-days follow-up, 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, 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, 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, at 12-months follow-up