Status:

RECRUITING

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

Lead Sponsor:

University of Leipzig

Conditions:

Peripheral Vascular Diseases

Kidney Diseases

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 (MA...

Detailed Description

PeriPREVENT is a prospective, multi-centre, controlled, open-label, 1:1 randomized superiority trial with two parallel groups. In the intervention group patients will undergo a routine peripheral ang...

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

Key Trial Info

Start Date :

April 14 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2029

Estimated Enrollment :

1960 Patients enrolled

Trial Details

Trial ID

NCT06656988

Start Date

April 14 2025

End Date

February 1 2029

Last Update

March 23 2026

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Tirol Kliniken Innsbruck

Innsbruck, Austria

2

Universitätsklinik für Innere Medizin II

Vienna, Austria

3

Kreiskrankenhaus Alsfeld

Alsfeld, Germany

4

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, Germany