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Clinical trial Recruiting at 8 sites Phase 3 Interventional Ages 18 and up

Automated carbon dioxide-guided angiography to spare iodinated dye during lower‑leg artery procedures

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

Run by University of Leipzig · NCT06656988 · Data updated 2026-11-12

This trial tests whether using automated carbon dioxide injections with a contrast‑sparing approach during infrainguinal peripheral vascular interventions reduces serious kidney problems within 90 days in adults with peripheral artery disease and reduced kidney function.

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Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1960 (estimated)
SponsorUniversity of Leipzig
Academic / other
Drugs / interventionschemotherapy
Locations11 sites (Innsbruck and 10 other locations)
StatusRecruiting
StartedApril 14, 2025
Main results expectedFebruary 2028
Study endsFebruary 2029
Registry record updatedMarch 23, 2026
Trial IDNCT06656988 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (≥18) with symptomatic infrainguinal peripheral artery disease scheduled for femoropopliteal and/or infrapopliteal intervention who have eGFR <60 ml/min/1.73 m² and a PVI CA‑AKI risk score ≥5, and for whom both CO2 and iodinated contrast imaging are feasible.

Probably not a fit

Patients with normal kidney function or very low risk of contrast‑associated kidney injury, those unable to tolerate CO2 angiography, those with planned full anaesthesia, or those with unstable or acute renal failure are unlikely to benefit from the contrast‑sparing strategy.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PeriPREVENT is a prospective, multicentre, open‑label, randomized 1:1 superiority Phase 3 trial comparing a maximal contrast‑sparing strategy using an automated CO2 injection system (with iodinated contrast as a bailout) against routine iodinated contrast media during infrainguinal peripheral vascular interventions. Adults with symptomatic peripheral arterial disease who have increased risk for contrast‑associated acute kidney injury (PVI risk score ≥5 and eGFR <60 ml/min/1.73 m²) are randomized when both angiographic strategies are considered feasible. The intervention arm uses CO2 angiography as the primary imaging method with iodinated contrast only as needed, while the control arm uses standard iodinated contrast; all patients are followed for clinical and kidney outcomes up to 12 months. The primary outcome is Major Adverse Kidney Events within 90 days (MAKE90).

Why it matters

Potential benefit: If successful, this approach could lower rates of acute kidney injury, need for dialysis, or kidney‑related death after peripheral angiography for at‑risk patients.

How similar studies have gone: Smaller observational studies and some randomized pilot trials have shown that CO2 angiography can markedly reduce iodinated contrast use and may lower kidney injury rates, but large randomized Phase 3 evidence is still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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) \&lt; 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 \&gt; 0.5 mg/dl or \&gt; 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 \&lt; 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 \&gt; 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

Where it's running

  • Tirol Kliniken Innsbruck
    Innsbruck, Austria     Recruiting
  • Universitätsklinik für Innere Medizin II
    Vienna, Austria     Recruiting
  • Kreiskrankenhaus Alsfeld
    Alsfeld, Germany     Recruiting
  • Universitäts-Herzzentrum Freiburg-Bad Krozingen
    Bad Krozingen, Germany     Recruiting
  • MVZ CCB Frankfurt und Main-Taunus GbR
    Frankfurt a.M., Germany     Recruiting
  • Universitätsklinikum Leipzig
    Leipzig, Germany     Recruiting
Show 5 more locations
  • Klinikum rechts der Isar der Technischen Universität München
    München, Germany     Recruiting
  • GRN - Klinik Weinheim
    Weinheim, Germany     Recruiting
  • Universitätsklinikum Bonn
    Bonn, Germany     Not yet recruiting
  • Klinikum Chemnitz gGmbH
    Chemnitz, Germany     Not yet recruiting
  • DIAKO Krankenhaus gGmbH Flensburg
    Flensburg, Germany     Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Peripheral Vascular Diseases 12Kidney Diseases 52University of Leipzig 16
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.