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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
EU CTIS ID: 2024-512876-37-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 [1] 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
You likely can't join if
- Very agitated patients
- 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
- 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
See the full eligibility criteria
- 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 [1] 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
- Very agitated patients
- 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
- 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.
- Previous participation in the PeriPREVENT trial or participation in other interventional trials. (Exceptions are described in the trial protocol)
- Suspected lack of compliance
- Pregnant or nursing women
- 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 < 20 ml/min/1.73 m² 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.