NCT06656988 A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
| NCT ID | NCT06656988 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Leipzig |
| Condition | Peripheral Vascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,960 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,960 participants in total. It began in 2025-04-14 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Sabine Steiner, Prof Dr
PRINCIPAL INVESTIGATOR
University Leipzig
Frequently Asked Questions
Who can join the NCT06656988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Vascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06656988 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,960 participants.
Is NCT06656988 currently recruiting?
Yes, NCT06656988 is actively recruiting participants. Contact the research team at angiologie@medizin.uni-leipzig.de for enrollment information.
Where is the NCT06656988 trial being conducted?
This trial is being conducted at Innsbruck, Austria, Vienna, Austria, Alsfeld, Germany, Bad Krozingen, Germany and 7 additional locations.
Who is sponsoring the NCT06656988 clinical trial?
NCT06656988 is sponsored by University of Leipzig. The principal investigator is Sabine Steiner, Prof Dr at University Leipzig. The trial plans to enroll 1,960 participants.