Could carbon dioxide replace contrast dye to save kidneys?
NCT ID NCT06656988
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using carbon dioxide gas instead of standard iodinated contrast dye during leg artery procedures can prevent serious kidney problems. About 1,960 people with peripheral artery disease who are at higher risk for kidney injury will be randomly assigned to receive either CO2 or standard dye. The main goal is to see if the CO2 approach reduces major adverse kidney events within 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- carbon dioxide (CO2)
- What this could lead to
- If successful, this approach could offer a safer way to perform leg artery procedures, reducing the risk of kidney injury for patients with vulnerable kidneys.
- What could go wrong
- This is a large Phase 3 trial, but CO2 imaging may not provide the same clarity as standard dye, potentially affecting procedure outcomes. The benefit may also vary by patient.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,960 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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) 2. Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and/or infrapopliteal lesions 3. 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 4. Both angiographic strategies seem feasible at the investigator's discretion 5. Age 18 years or older 6. Written informed consent Exclusion Criteria: 1. Very agitated patients 2. Patients with planned full anaesthesia during procedure 3. Patients with a life-expectancy less than one year 4. Patients confined to bed that are completely non-ambulatory 5. 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 6. 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 7. Advanced chronic kidney disease (CKD) with an eGFR \< 30 ml/min/1.73m² and/or dialysis 8. Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent 9. Acute or chronic pulmonary disease requiring oxygen therapy 10. Patients with known patent foramen ovale or atrial septal defect 11. Patients with planned nitrous oxide anaesthesia during intervention 12. Patients with manifest hyperthyroidism or manifest thyrotoxicosis 13. Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure 14. Patients with decompensated heart failure 15. Patients with manifest tetany 16. 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 17. Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure 18. 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. 19. Participation in other interventional trials. Exceptions are described in the trial protocol. 20. Suspected lack of compliance 21. Pregnant or nursing women
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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DIAKO Krankenhaus gGmbH Flensburg
NOT_YET_RECRUITINGFlensburg, 24939, Germany
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GRN - Klinik Weinheim
RECRUITINGWeinheim, Germany
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Klinikum Chemnitz gGmbH
NOT_YET_RECRUITINGChemnitz, 09116, Germany
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Klinikum rechts der Isar der Technischen Universität München
RECRUITINGMünchen, Germany
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Kreiskrankenhaus Alsfeld
RECRUITINGAlsfeld, Germany
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MVZ CCB Frankfurt und Main-Taunus GbR
RECRUITINGFrankfurt a.M., Germany
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Tirol Kliniken Innsbruck
RECRUITINGInnsbruck, Austria
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Universitäts-Herzzentrum Freiburg-Bad Krozingen
RECRUITINGBad Krozingen, Germany
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Universitätsklinik für Innere Medizin II
RECRUITINGVienna, Austria
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Universitätsklinikum Bonn
NOT_YET_RECRUITINGBonn, 53127, Germany
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Universitätsklinikum Leipzig
RECRUITINGLeipzig, Germany
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