RecruitingPhase 3NCT06656988

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

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


Sponsor

University of Leipzig

Enrollment

1,960 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CO2 and a drug called Iodinated Contrast Media (ICM) for people with kidney diseases and peripheral vascular diseases. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCO2

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

DRUGIodinated 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

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NCT06656988


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