A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leipzig
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic peripheral arterial disease presenting with either acute symptoms (Rutherford clinical categories I-IIb) or chronic symptoms (Fontaine stages IIb-IV or Rutherford clinical categories 2-6)
Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and/or infrapopliteal lesions
Increased risk of CA-AKI identified by a baseline risk score of ≥ 5 points based on a published dedicated PVI risk score and a pre-angiographic estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m²
Both angiographic strategies seem feasible at the investigator's discretion
Disqualifiers
Very agitated patients
Patients with planned full anaesthesia during procedure
Patients with a life-expectancy less than one year
Patients confined to bed that are completely non-ambulatory
Trial design
Design model
Parallel
Treatments tested in this trial
CO2
DrugCO2 will be used as contrast medium sparing strategy during peripheral angiography
Iodinated Contrast Media (ICM)
DrugIodinated contrast medium will be used as in routine care during peripheral angiography
Treatment groups
1,960 Participants
are divided into 2 treatment groupsGroup A: Standard angiography using iodinated Contrast Medium (CM)Active comparator 1 intervention
Group B: Contrast medium sparing strategy using CO2 injection as contrast agent, bailout option iodinated CMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MAKE 90
major adverse kidney events
Time frame
From the day of the peripheral vascular intervention (day 0) to day 90Sponsors and contacts
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Source ClinicalTrials.gov