CO2 Injection Strategy for Kidney Health in Vascular Procedures

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

Recruiting Phase 3 Interventional Study
Peripheral Vascular Diseases Kidney Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,960 (estimated)
Sponsor
University of Leipzig · Other
Who this trial is looking for

This trial is looking for people with certain blood vessel problems who are at risk for kidney issues. Participants will receive a specific kind of treatment during a procedure to help manage their condition without using certain contrast materials that may harm their kidneys.

Are You a Good Fit for This Trial?
Rules you out Severe kidney diseaseCurrent use of nephrotoxic agentsAcute or chronic pulmonary diseaseHeart failure

You may be able to join if

  • I have symptoms of peripheral arterial disease.
  • I need a procedure for my leg arteries.
  • I have a higher risk of kidney injury according to my doctor.
  • I am at least 18 years old.
  • I have agreed to take part in the trial.

You may not be able to join if

  • I am very agitated.
  • I need full anesthesia for my procedure.
  • I do not expect to live for more than a year.
  • I cannot move on my own.
  • I have recent acute renal failure or unstable kidney function.
  • I had a contrast medium in the last week.
  • I have advanced chronic kidney disease.
  • I am pregnant or nursing.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This 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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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) 2. Planned peripheral vascular intervention of infrainguinal arteries due to…
Contacts

Sabine Steiner, Prof Dr

+493419718770

angiologie@medizin.uni-leipzig.de

CONTACT