The primary objective of the trial is to evaluate if an iodinated contrast medium sparing strategy using automated Carbon Dioxide (CO2) Injection prevents Major Adverse Kidney Events up to 90 days (MAKE90) in patients at moderately elevated risk for contrast-associated acute kidney injury (CA-AKI) undergoing infrainguinal peripheral vascular interventions (PVI).
PeriPREVENT is a prospective, multi-centre, controlled, open-label, 1:1 randomized superiority trial with two parallel groups. In the intervention group patients will undergo a routine peripheral angiographic intervention (PVI) using a maximally contrast medium sparing strategy with an automated CO2 injection system including iodinated CM as bailout option in case of insufficient image quality or patient's intolerability of CO2 angiography. The control intervention is routine PVI using iodinated contrast media (CM) as standard of care. All patients are followed up until 12 months after the PVI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,960
CO2 will be used as contrast medium sparing strategy during peripheral angiography
Iodinated contrast medium will be used as in routine care during peripheral angiography
Tirol Kliniken Innsbruck
Innsbruck, Austria
RECRUITINGUniversitätsklinik für Innere Medizin II
Vienna, Austria
RECRUITINGKreiskrankenhaus Alsfeld
Alsfeld, Germany
RECRUITINGUniversitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany
RECRUITINGUniversitätsklinikum Bonn
Bonn, Germany
NOT_YET_RECRUITINGKlinikum Chemnitz gGmbH
Chemnitz, Germany
NOT_YET_RECRUITINGDIAKO Krankenhaus gGmbH Flensburg
Flensburg, Germany
NOT_YET_RECRUITINGMVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt a.M., Germany
RECRUITINGUniversitätsklinikum Leipzig
Leipzig, Germany
RECRUITINGKlinikum rechts der Isar der Technischen Universität München
München, Germany
RECRUITING...and 1 more locations
MAKE 90
major adverse kidney events
Time frame: From the day of the peripheral vascular intervention (day 0) to day 90
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