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

NCT06656988 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1960

Last updated 2026-03-23

No results posted yet for this study

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).

Conditions

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

Sponsors & Collaborators

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Sabine Steiner, Prof Dr · University Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-14
Primary Completion
2028-02-29
Completion
2029-02-28

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656988 on ClinicalTrials.gov