PCI with use of IVL
DeviceUse of IVL for the treatment of calcific coronary artery lesions at operator's discretion
Other names: Shockwave intravascular lithotripsy system
NCT Number: NCT06577038
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Cliniques Universitaires Saint-Luc, Brussels, Belgium
The primary objectives are:
The secondary objectives are:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of IVL for the treatment of calcific coronary artery lesions at operator's discretion
Other names: Shockwave intravascular lithotripsy system
Time frame: Periprocedurally and from hospital admission to discharge (an average of 2 days)
success in facilitating stent delivery with <30% residual stenosis and without in-hospital MACE
Time frame: At 30 days follow-up
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 3 months follow-up
rate of MACE at 3-months following the index procedure
Time frame: At 6 months follow-up
rate of MACE at 6-months following the index procedure
Time frame: At 12 months follow-up
rate of MACE at 12-months following the index procedure
Time frame: 30-days, 3-, 6- and 12-months
at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure
Time frame: at 30-days follow-up
at any time point, any type of angina at 30-days follow-up
Time frame: at 3 months follow-up
at any time point, any type of angina at 3 months follow-up
Time frame: at 6 months follow-up
at any time point, any type of angina at 6 months follow-up
Time frame: at 12-months follow-up
at any time point, any type of angina at 12-months follow-up
Leiden University Medical Center
Other
Prospective, International, Multicenter, All-comers Registry for the Study of Intravascular Lithotripsy in Coronary Interventions
Acronym: BENELUX-IVL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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