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Could carbon dioxide replace contrast dye to save kidneys?

NCT ID NCT06656988

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,960 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    11 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • DIAKO Krankenhaus gGmbH Flensburg

    NOT_YET_RECRUITING

    Flensburg, 24939, Germany

  • GRN - Klinik Weinheim

    RECRUITING

    Weinheim, Germany

  • Klinikum Chemnitz gGmbH

    NOT_YET_RECRUITING

    Chemnitz, 09116, Germany

  • Klinikum rechts der Isar der Technischen Universität München

    RECRUITING

    München, Germany

  • Kreiskrankenhaus Alsfeld

    RECRUITING

    Alsfeld, Germany

  • MVZ CCB Frankfurt und Main-Taunus GbR

    RECRUITING

    Frankfurt a.M., Germany

  • Tirol Kliniken Innsbruck

    RECRUITING

    Innsbruck, Austria

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen

    RECRUITING

    Bad Krozingen, Germany

  • Universitätsklinik für Innere Medizin II

    RECRUITING

    Vienna, Austria

  • Universitätsklinikum Bonn

    NOT_YET_RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Germany

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