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
- 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)
- Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and/or infrapopliteal lesions
- 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
- Both angiographic strategies seem feasible at the investigator's discretion
- Age 18 years or older
- Written informed consent
Exclusion
- Very agitated patients
- Patients with planned full anaesthesia during procedure
- Patients with a life-expectancy less than one year
- Patients confined to bed that are completely non-ambulatory
- 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
- 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
- Advanced chronic kidney disease (CKD) with an eGFR \< 30 ml/min/1.73m² and/or dialysis
- Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent
- Acute or chronic pulmonary disease requiring oxygen therapy
- Patients with known patent foramen ovale or atrial septal defect
- Patients with planned nitrous oxide anaesthesia during intervention
- Patients with manifest hyperthyroidism or manifest thyrotoxicosis
- Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure
- Patients with decompensated heart failure
- Patients with manifest tetany
- 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
- Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure
- 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.
- Participation in other interventional trials. Exceptions are described in the trial protocol.
- Suspected lack of compliance
- 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 5 2026
Active Locations (11)
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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