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Taking people in GermanyPhase 3

Carbon dioxide injection to protect kidneys during leg artery procedures in peripheral artery disease

Tests carbon dioxide injection to protect kidneys in people with peripheral artery disease.

Key facts

Who runs it
Universitaet Leipzig
Where
Alsfeld, Bad Krozingen, Berlin, Bonn, Chemnitz, Coburg, Flensburg, Frankfurt Am Main, Hamburg, Leipzig, Munich, and Weinheim, GermanySee the 12 sitesAlso in 1 other country, 2 sites
Registry 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
Status
Recruiting
Phase
Phase 3
People taking part
1,960 people, planned
Started
11 Apr 2025
Expected to end
31 May 2029
Type of study
Interventional
Record updated
11 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral arterial disease who have symptoms and a planned procedure on the leg arteries below the groin. They must have a raised risk of kidney injury from contrast dye. The trial compares imaging with carbon dioxide (CO2) instead of iodine contrast dye.

Age
18 years or older
Sex
All
Disease stage
Symptomatic peripheral arterial disease. Acute symptoms (Rutherford categories I-IIb) or chronic symptoms (Fontaine stages IIb-IV or Rutherford categories 2-6). Planned procedure for femoropopliteal and/or infrapopliteal lesions.
Earlier treatment
No surgery or procedure in the 30 days before (except minor amputations). No iodinated contrast within 7 days before with a change in SCr of ≥ 0.1 mg/dl.
Biomarker or test result
Kidney injury risk score of ≥ 5 points and eGFR < 60 ml/min/1.73 m² before the procedure.

Main reasons for not taking part

  • Advanced kidney disease with eGFR < 20 ml/min/1.73 m², dialysis, or acute or unstable kidney function
  • Known patent foramen ovale or atrial septal defect (a hole in the heart wall)
  • Pregnant or breastfeeding women, or fertile women without birth control
  • Lung disease needing oxygen, or life expectancy less than one year
  • Planned full anaesthesia or nitrous oxide anaesthesia, or another planned procedure needing > 10 ml of iodinated contrast within 90 days

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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 [1] 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
  • Age 18 years or older
  • Written informed consent

Who cannot take part

  • Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure
  • Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure
  • Previous participation in the PeriPREVENT trial or participation in other interventional trials. (Exceptions are described in the trial protocol)
  • Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent
  • Acute or chronic pulmonary disease requiring oxygen therapy
  • Known acute renal failure or known unstable renal function as evidenced by a recent increase in serum creatinine (SCr) of > 0.5 mg/dl or > 25% within 7 days
  • Iodinated contrast medium exposure within 7 days prior to procedure with change in SCr ≥ 0.1 mg/dl on two SCr measures ≥ 24 h apart
  • Advanced chronic kidney disease (CKD) with an eGFR < 20 ml/min/1.73 m² and/or dialysis
  • Very agitated patients
  • Patients with known patent foramen ovale or atrial septal defect
  • Patients with planned nitrous oxide anaesthesia during intervention
  • Patients with manifest hyperthyroidism or manifest thyrotoxicosis
  • Planned further procedure with a need for > 10 ml of iodinated contrast medium (CM) in any location (e.g., CT scan, coronary angiography) within a period of 90 days
  • Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) until day 30 after PVI
  • Suspected lack of compliance
  • Pregnant or nursing women
  • 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

Where in Germany

Also in 1 other country, 2 sites

  • Kreiskrankenhaus des Vogelsbergkreises in Alsfeld GmbHAlsfeld, GermanyTaking people
  • Medical Center - University Of FreiburgBad Krozingen, GermanyTaking people
  • Evangelisches Krankenhaus Konigin Elisabeth Herzberge gGmbHBerlin, GermanyTaking people
  • Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
  • Klinikum Chemnitz gGmbHChemnitz, GermanyTaking people
  • SANA Kliniken Oberfranken Coburg GmbHCoburg, GermanyTaking people
  • DIAKO Krankenhaus gGmbHFlensburg, GermanyTaking people
  • MVZ CCB Frankfurt Und Main-Taunus GbRFrankfurt Am Main, GermanyTaking people
  • University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
  • Universitaetsklinikum Leipzig AorLeipzig, GermanyTaking people
  • Klinikum rechts der Isar der TU Muenchen AöRMunich, GermanyTaking people
  • GRN Gesundheitszentren Rhein-Neckar gGmbHWeinheim, GermanyTaking people

About the trial

What the trial wants to find out

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).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
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
Plain-language title
Carbon dioxide injection to protect kidneys during leg artery procedures in peripheral artery diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
11 November 2026