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

A vizsgálat adatai

Ki végzi

Universitaet Leipzig

Azonosító

EU 2024-512876-37-00

A regiszteradat frissítve

2026. november 11.

Eredeti leírás

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).A teljes eredeti leírásKevesebb

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).

Bevonási feltételek: 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 [1] 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.

Kizáró feltételek: Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure; Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure; Previous participation in the PeriPREVENT trial or participation in other interventional trials. (Exceptions are described in the trial protocol); 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; 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 < 20 ml/min/1.73 m² and/or dialysis; Very agitated patients; 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; 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; 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; Suspected lack of compliance; Pregnant or nursing women; 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.

EU CTIS 2024-512876-37-00