Peripheral Vascular DiseasesPhase 3PeriPREVENTNCT06656988
A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
A Phase 3 study testing CO2 and Iodinated Contrast Media (ICM) in people with Peripheral Vascular Diseases and Kidney Diseases, run by University of Leipzig at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Kidney Diseases
- What is being tested?
- CO2 and Iodinated Contrast Media (ICM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,960 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 14 Apr 2025to Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
Germany9 sites, 9 recruiting
- Recruiting
Kreiskrankenhaus Alsfeld
Alsfeld
- Recruiting
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen
- Not yet recruiting
Universitätsklinikum Bonn
Bonn, 53127
- Not yet recruiting
Klinikum Chemnitz gGmbH
Chemnitz, 09116
- Not yet recruiting
DIAKO Krankenhaus gGmbH Flensburg
Flensburg, 24939
- Recruiting
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt a.M.
- Recruiting
Universitätsklinikum Leipzig
Leipzig
- Recruiting
Klinikum rechts der Isar der Technischen Universität München
München
- Recruiting
GRN - Klinik Weinheim
Weinheim
Austria2 sites, 2 recruiting
- Recruiting
Tirol Kliniken Innsbruck
Innsbruck
- Recruiting
Universitätsklinik für Innere Medizin II
Vienna
About this study
Official title: 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
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).
Read the 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 angiographic intervention (PVI) using a maximally contrast medium sparing strategy with an automated CO2 injection system including iodinated CM as bailout option in case of insufficient image quality or patient's intolerability of CO2 angiography.
The control intervention is routine PVI using iodinated contrast media (CM) as standard of care.
All patients are followed up until 12 months after the PVI.
- Conditions
- Peripheral Vascular Diseases, Kidney Diseases
- Being tested
- CO2, Iodinated Contrast Media (ICM)
- Keywords
- carbon dioxide, contrast medium, iodinated contrast medium, CA-AKI, angiography, angioplasty
- Medical subject headings
- Peripheral Vascular Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2Drug
Also called carbon dioxide
CO2 will be used as contrast medium sparing strategy during peripheral angiography
Iodinated Contrast Media (ICM)Drug
Iodinated contrast medium will be used as in routine care during peripheral angiography
| Study group | Role | What they receive |
|---|---|---|
| Standard angiography using iodinated Contrast Medium (CM) | Active comparator | For 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. Receives: Drug: Iodinated Contrast Media (ICM) |
| Contrast medium sparing strategy using CO2 injection as contrast agent, bailout option iodinated CM | Experimental | For 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. Receives: Drug: CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAKE 90
major adverse kidney events
Measured: From the day of the peripheral vascular intervention (day 0) to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start14 Apr 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Steiner, University of Leipzig
- Investigators
- Sabine Steiner, Prof Dr, Principal investigator, University Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656988
- Sponsor's protocol ID
- PeriPREVENT
- Other IDs
- 2024-512876-37-00
- Acronym
- PeriPREVENT
- Status last verified
- Mar 2026
- First submitted
- 16 Oct 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06656988
- Acronym / sponsor ID
- PeriPREVENT / PeriPREVENT
- Conditions
- Peripheral Vascular Diseases, Kidney Diseases
- Keywords
- carbon dioxide, contrast medium, iodinated contrast medium, CA-AKI, angiography, angioplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,960 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 angiographic intervention (PVI) using a maximally contrast medium sparing strategy with an automated CO2 injection system including iodinated CM as bailout option in case of insufficient image quality or patient's intolerability of CO2 angiography.
The control intervention is routine PVI using iodinated contrast media (CM) as standard of care.
All patients are followed up until 12 months after the PVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard angiography using iodinated Contrast Medium (CM) | Active comparator | Drug: Iodinated Contrast Media (ICM)For 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 | Experimental | Drug: CO2For 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2Also: carbon dioxideCO2 will be used as contrast medium sparing strategy during peripheral angiography | Drug | Contrast medium sparing strategy using CO2 injection as contrast agent, bailout option iodinated CM |
| Iodinated Contrast Media (ICM)Iodinated contrast medium will be used as in routine care during peripheral angiography | Drug | Standard angiography using iodinated Contrast Medium (CM) |
Primary outcome
MAKE 90
Time frame: From the day of the peripheral vascular intervention (day 0) to day 90
major adverse kidney events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabine Steiner, Prof Dr principal investigator
University Leipzig
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CO2 and Iodinated Contrast Media (ICM) in people with Peripheral Vascular Diseases and Kidney Diseases, run by University of Leipzig at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Steiner, Prof Dr (+493419718770, angiologie@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAKE 90 (time frame: From the day of the peripheral vascular intervention (day 0) to day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.