Study on Preventing Kidney Problems in Peripheral Arterial Disease Patients Using Carbon Dioxide and Iopamidol, Iomeprol, and Iopromide During Vascular Procedures

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What is this study about?

This clinical trial is focused on studying a condition known as Peripheral Arterial Disease (PAD), which affects blood flow in the arteries outside of the heart and brain, often in the legs. The study is exploring a new approach to reduce the risk of kidney problems that can occur after certain medical procedures. This approach involves using a special gas called Carbon Dioxide (CO2) instead of traditional iodinated contrast during procedures to open up blocked arteries in the legs. The goal is to see if this method can help prevent serious kidney issues, known as Major Adverse Kidney Events (MAKE), in patients who are at a higher risk of kidney damage from these procedures.

The trial will include several different types of contrast solutions, such as Solutrast, Imeron, Ultravist, VISIPAQUE, ACCUPAQUE, and Optiray, which are used to improve the visibility of blood vessels during imaging tests. These solutions contain substances like iopamidol, iomeprol, iopromide, iodixanol, iohexol, and ioversol. The study will compare the effects of using these traditional contrast solutions with the new CO2 method to determine which is more effective in preventing kidney problems.

Participants in the study will undergo a procedure called infrainguinal peripheral vascular intervention (PVI), which is a treatment for blocked arteries in the legs. The study will monitor the participants for up to 90 days after the procedure to assess the occurrence of kidney-related issues. The aim is to find out if the CO2 method can reduce the risk of kidney damage compared to the use of traditional contrast solutions. This research is important for improving the safety of medical procedures for patients with PAD who are at risk of kidney problems.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, procedures, and potential risks and benefits. You will be required to provide written informed consent, confirming your understanding and willingness to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes evaluating your medical history, current health status, and specific criteria such as your risk of kidney injury and the condition of your peripheral arteries.

3 pre-procedure preparation

Before the procedure, you will undergo routine tests to assess your kidney function and overall health. These tests help ensure that you are in a suitable condition to proceed with the intervention.

4 procedure day

On the day of the procedure, you will receive an injection of a contrast medium, which is a special dye used to improve the visibility of blood vessels during imaging. The contrast medium may include substances such as iopamidol, iomeprol, or iodixanol, administered through an intravenous (IV) injection or infusion.

The procedure involves using automated carbon dioxide (CO2) injection to minimize the amount of contrast medium needed. This approach aims to reduce the risk of kidney injury.

5 post-procedure monitoring

After the procedure, you will be monitored for any immediate reactions or complications. Your kidney function will be closely observed to detect any signs of acute kidney injury.

6 follow-up visits

You will have scheduled follow-up visits to assess your recovery and kidney health. These visits will occur up to 90 days after the procedure to monitor for any major adverse kidney events.

During these visits, additional tests may be conducted to evaluate your kidney function and ensure that no significant decline has occurred.

Who Can Join the Study?

Have symptomatic peripheral arterial disease (PAD), which means you have symptoms due to poor blood flow in your legs. This can be either sudden symptoms or long-term symptoms.
Plan to have a procedure called a peripheral vascular intervention (PVI) on the arteries below your groin area, specifically in the thigh or lower leg.
Have an increased risk of kidney injury from the contrast dye used in medical imaging. This is determined by a risk score of 5 or more points and a kidney function test result (eGFR) of less than 60.
Both treatment strategies using imaging seem possible according to the doctor’s judgment.
Be 18 years or older.
Provide written informed consent, which means you agree to participate after understanding the study details.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to contrast media. Contrast media are substances used in medical imaging to help highlight structures in the body.
Patients with severe kidney disease. This means the kidneys are not working well enough to filter waste from the blood.
Patients who have had a kidney transplant. This is when a person receives a new kidney from a donor.
Patients with severe heart failure. This is a condition where the heart cannot pump blood effectively.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients with uncontrolled high blood pressure. This means blood pressure that is not managed well with medication or lifestyle changes.
Patients with severe liver disease. This is when the liver is not functioning properly.
Patients with active infection. This means having an ongoing infection that is not yet treated or resolved.
Patients with blood clotting disorders. These are conditions that affect the blood’s ability to clot properly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country
Klinikum Coburg GmbH	Coburg	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
MVZ CCB Frankfurt Und Main-Taunus GbR	Frankfurt	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Glm Gadklcotekmlorrmpv Rckltqinmmgh gugjd	Weinheim	Germany
Esopjhirmhtaz Keiftxghjbx Kscnvny Eameuauys Hmmzzxjos gxfdb	Berlin	Germany
Dbfpe Kvaidiyupxt gzpaw	Flensburg	Germany
Kprqqlphbwgntevp dha Vqzgjosewesakwnxi ie Ajimond Ghrd	Alsfeld	Germany
Udscxlshfd Mbfvqqs Cldzmg Hrqnteepufeoeixmf	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.11.2024
Germany	Recruiting	01.11.2024

Trial locations

Investigated drugs:

Carbon Dioxide (CO2) Injection is a method used in medical procedures to help doctors see blood vessels more clearly. In this trial, it is used as an alternative to traditional contrast dyes that contain iodine. The goal is to reduce the risk of kidney problems that can occur when iodine-based dyes are used, especially in patients who already have a higher risk of kidney issues. By using CO2, doctors hope to perform the necessary procedures while keeping the kidneys safe.

Investigated diseases:

Peripheral arterial occlusive disease

Peripheral Arterial Disease (PAD) – Peripheral Arterial Disease is a condition where the arteries that supply blood to the limbs, usually the legs, become narrowed or blocked. This narrowing is typically due to atherosclerosis, which is the buildup of fatty deposits on the artery walls. As the disease progresses, it can lead to reduced blood flow, causing symptoms such as leg pain, cramping, or fatigue, especially during physical activities like walking. Over time, the reduced blood flow can result in more severe symptoms, including pain at rest, non-healing wounds, or ulcers on the feet or toes. In advanced stages, PAD can lead to critical limb ischemia, where the blood flow is so restricted that it threatens the viability of the limb. The progression of PAD can vary, with some individuals experiencing slow progression and others facing rapid worsening of symptoms.

Trial ID:

2024-512876-37-00

Protocol code:

PeriPREVENT

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Kidney Problems in Peripheral Arterial Disease Patients Using Carbon Dioxide and Iopamidol, Iomeprol, and Iopromide During Vascular Procedures

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?