What is the automated CO2 injection strategy studying for peripheral vascular diseases?

This trial studies if using an automated CO2 injection system during peripheral vascular interventions can reduce major kidney problems within 90 days after the procedure. It compares this method to standard iodinated contrast media in patients at risk for kidney injury. The University of Leipzig leads this research to improve outcomes in these vascular procedures.

Who may be eligible for this peripheral vascular disease clinical trial?

Adults aged 18 or older with symptomatic peripheral arterial disease who are scheduled for infrainguinal vascular intervention and have an increased risk for kidney injury may be eligible. Participants must be able to undergo either contrast method and give informed consent. Please review eligibility criteria for more details.

Is there any cost to participate in this peripheral vascular disease clinical trial?

Study-related care, including the study procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06656988

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

Research Sites

52 weeks

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

Sabine Steiner, Prof Dr

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