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RECRUITING
NCT06656988
PHASE3

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

Sponsor: University of Leipzig

View on ClinicalTrials.gov

Summary

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).

Official title: A Contrast Medium Sparing Strategy Using Automated Carbon Dioxide Injection During PERIpheral Vascular Interventions for PREVENTion of Major Adverse Kidney Events (MAKE): the PeriPREVENT Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1960

Start Date

2025-04-14

Completion Date

2029-02

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

CO2

CO2 will be used as contrast medium sparing strategy during peripheral angiography

DRUG

Iodinated Contrast Media (ICM)

Iodinated contrast medium will be used as in routine care during peripheral angiography

Locations (11)

Tirol Kliniken Innsbruck

Innsbruck, Austria

Universitätsklinik für Innere Medizin II

Vienna, Austria

Kreiskrankenhaus Alsfeld

Alsfeld, Germany

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, Germany

Universitätsklinikum Bonn

Bonn, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

DIAKO Krankenhaus gGmbH Flensburg

Flensburg, Germany

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt a.M., Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Klinikum rechts der Isar der Technischen Universität München

München, Germany

GRN - Klinik Weinheim

Weinheim, Germany