Actively Recruiting
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
Led by University of Leipzig · Updated on 2026-03-23
1960
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using an automated Carbon Dioxide (CO2) injection system during infrainguinal peripheral vascular interventions (PVI) can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury (CA-AKI). This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.
CONDITIONS
Brief Title
A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic peripheral arterial disease with acute (Rutherford I-IIb) or chronic (Fontaine IIb-IV or Rutherford 2-6) symptoms
- Planned infrainguinal peripheral vascular intervention for femoropopliteal and/or infrapopliteal lesions
- Increased risk of contrast-associated acute kidney injury with baseline risk score ≥ 5 and eGFR < 60 ml/min/1.73 m²
- Both angiographic strategies considered feasible by the investigator
- Age 18 years or older
- Provided written informed consent
You will not qualify if you...
- Very agitated patients
- Planned full anesthesia during procedure
- Life expectancy less than one year
- Completely non-ambulatory and confined to bed
- Known acute renal failure or unstable renal function with recent creatinine increase > 0.5 mg/dl or > 25% within 7 days
- Iodinated contrast exposure within 7 days before procedure with creatinine change ≥ 0.1 mg/dl on two measures
- Advanced chronic kidney disease with eGFR < 30 ml/min/1.73 m² or dialysis
- Current use of nephrotoxic agents or active chemotherapy
- Acute or chronic lung disease requiring oxygen therapy
- Known patent foramen ovale or atrial septal defect
- Planned nitrous oxide anesthesia during intervention
- Manifest hyperthyroidism or thyrotoxicosis
- Allergies to iodinated contrast media that cannot be pre-treated
- Decompensated heart failure
- Manifest tetany
- Planned procedures needing > 10 ml iodinated contrast within 90 days
- Surgical procedures (except minor amputations) within 30 days before or 90 days after intervention
- Fertile women without effective contraception until 30 days after intervention
- Participation in other interventional trials (exceptions apply)
- Suspected lack of compliance
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (intervention day)
Participants undergo a planned infrainguinal peripheral vascular intervention (PVI) using either a contrast medium sparing strategy with automated CO2 injection or routine iodinated contrast media during peripheral angiography.
1 intervention visit (in-person)
Duration - Up to 12 months after intervention
Participants are followed up to monitor outcomes and any major adverse kidney events for 12 months after the PVI.
Follow-up visits as per trial schedule up to 12 months
Trial Site Locations
Total: 11 locations
1
Tirol Kliniken Innsbruck
Innsbruck, Austria
Actively Recruiting
2
Universitätsklinik für Innere Medizin II
Vienna, Austria
Actively Recruiting
3
Kreiskrankenhaus Alsfeld
Alsfeld, Germany
Actively Recruiting
4
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany
Actively Recruiting
5
Universitätsklinikum Bonn
Bonn, Germany, 53127
Not Yet Recruiting
6
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116
Not Yet Recruiting
7
DIAKO Krankenhaus gGmbH Flensburg
Flensburg, Germany, 24939
Not Yet Recruiting
8
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt a.M., Germany
Actively Recruiting
9
Universitätsklinikum Leipzig
Leipzig, Germany
Actively Recruiting
10
Klinikum rechts der Isar der Technischen Universität München
München, Germany
Actively Recruiting
11
GRN - Klinik Weinheim
Weinheim, Germany
Actively Recruiting
Research Team
S
Sabine Steiner, Prof Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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