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

Phase 3

Not yet recruiting

• Conditions: Peripheral Vascular Diseases; Kidney Diseases
• Interventions: Drug: Iodinated Contrast Media (ICM); Drug: CO2

• Registration Number: NCT06656988
• Lead Sponsor: University of Leipzig

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).

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24
• Study Start: 2024-11
• Primary Completion: 2028-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1960

Inclusion Criteria

1. Symptomatic peripheral arterial disease presenting with either acute symptoms (Rutherford clinical categories I-IIb) and/or chronic symptoms (Rutherford clinical categories 3-6)
2. Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and/or infrapopliteal lesions
3. 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
4. Both angiographic strategies seem feasible at the investigator's discretion
5. Age 18 years or older
6. Written informed consent

Exclusion Criteria

1. Very agitated patients
2. Patients with planned full anaesthesia during procedure
3. Patients with a life-expectancy less than one year
4. Patients confined to bed that are completely non-ambulatory
5. 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
6. 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
7. Advanced chronic kidney disease (CKD) with an eGFR < 30 ml/min/1.73m² and/or dialysis
8. Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent
9. Acute or chronic pulmonary disease requiring oxygen therapy
10. Patients with known patent foramen ovale or atrial septal defect
11. Patients with planned nitrous oxide anaesthesia during intervention
12. Patients with manifest hyperthyroidism or manifest thyrotoxicosis
13. Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure
14. Patients with decompensated heart failure
15. Patients with manifest tetany
16. 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
17. Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure
18. 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.
19. Participation in other interventional trials. Exceptions are described in the trial protocol.
20. Suspected lack of compliance
21. Pregnant or nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard angiography using iodinated Contrast Medium (CM)	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	CO2	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.

Primary Outcome Measures

Name	Time	Method
MAKE 90	From the day of the peripheral vascular intervention (day 0) to day 90	major adverse kidney events

Trial Locations

Locations (9)

Tirol Kliniken Innsbruck; 🇦🇹 Innsbruck, Austria

Universitätsklinik für Innere Medizin II; 🇦🇹 Wien, Austria

Kreiskrankenhaus Alsfeld; 🇩🇪 Alsfeld, Germany

Universitäts-Herzzentrum Freiburg-Bad Krozingen; 🇩🇪 Bad Krozingen, 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

MEDINOS Kliniken des Landkreises Sonneberg GmbH; 🇩🇪 Sonneberg, Germany

GRN - Klinik Weinheim; 🇩🇪 Weinheim, Germany