A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
PeriPREVENT
2 other identifiers
interventional
1,960
2 countries
11
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 (MAKE90) in patients at moderately elevated risk for contrast-associated acute kidney injury (CA-AKI) undergoing infrainguinal peripheral vascular interventions (PVI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2025
Typical duration for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedStudy Start
First participant enrolled
April 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
March 23, 2026
March 1, 2026
2.8 years
October 16, 2024
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MAKE 90
major adverse kidney events
From the day of the peripheral vascular intervention (day 0) to day 90
Study Arms (2)
Standard angiography using iodinated Contrast Medium (CM)
ACTIVE COMPARATORFor patients randomised in the control group, a planned infrainguinal peripheral vascular intervention (PVI, not subject to the trial) will be performed with iso-osmolar or low-osmolar iodinated CM as contrast agent. The trial sites may use iodinated CM as defined per local routine. In line with current recommendations , the use of high-osmolar CM will be prohibited in the trial.
Contrast medium sparing strategy using CO2 injection as contrast agent, bailout option iodinated CM
EXPERIMENTALFor patients randomised in the intervention group, a planned infrainguinal peripheral vascular intervention (PVI, not subject to the trial) will be performed with CO2 as contrast agent. For the CO2 injection the Angiodroid® Injector will be used according to the recent user manual. The use of the Angiodroid® system allows a fully automatic injection with digital control. Automatic CO2 injection enhances patient tolerability as the gas injection is performed in a less explosive, more controlled manner. Iodinated CM (as described in the above section) is used as bailout option in case of inadequate image quality or intraprocedural intolerance of CO2 angiography by the patient. The reasons for use and the amount of CM must be carefully recorded.
Interventions
CO2 will be used as contrast medium sparing strategy during peripheral angiography
Iodinated contrast medium will be used as in routine care during peripheral angiography
Eligibility Criteria
You may qualify 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 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 may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Tirol Kliniken Innsbruck
Innsbruck, Austria
Universitätsklinik für Innere Medizin II
Vienna, Austria
Kreiskrankenhaus Alsfeld
Alsfeld, Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
DIAKO Krankenhaus gGmbH Flensburg
Flensburg, 24939, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt a.M., Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum rechts der Isar der Technischen Universität München
München, Germany
GRN - Klinik Weinheim
Weinheim, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabine Steiner, Prof Dr
University Leipzig
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
October 16, 2024
First Posted
October 24, 2024
Study Start
April 14, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The study protocol is made publicly available with the approval via CTIS.
- Access Criteria
- Please contact the coordinating investigator.
After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data that underlie published results will be shared after de-identification. This requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the meta-analysis. Summary statistics that go beyond the scope of published material will be made available to researchers for meta-analysis upon reasonable request and if the necessary data analysis is not unduly time-consuming. Together with publication of the main results, the statistical analysis plan will be made publicly available. The trial protocol will be published in a medical journal as soon as possible after approval of the trial.