Comparing gadopiclenol with Gadoterate meglumine (Dotarem) for steno-occlusive disease

Exclusion

• −Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.
• −by testing on siteTrial siteA hospital or clinic where a study is actually run.Read more → at the institution (serum βHCG or urine)
• −by surgical history (e.g., tubal ligation or hysterectomy)
• −post-menopausal with a minimum 1 year without menses.
• −Has severe renal impairment defined as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula.
• −Has known or suspected acute kidney injury (AKI) based on: a. Increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours or b. Increase in serum creatinine to ≥ 1.5 times baselineBaselineYour starting measurements, taken before treatment begins.Read more →, which is known or presumed to have occurred within prior 7 days or c. Urine volume \< 0.5 mL/kg/h for 6 hours
• −Has received any contrast agent (for MRI, CT, DSA) prior to the first IMP administration or is scheduled to receive any contrast agent between the two MRA or after the second IMP administration.
• −Has any contraindications to MRI.
• −Is suffering from severe claustrophobia.
• −Has received an investigational drug or medical device before admission into this study or scheduled to receive any investigational treatment in the course of the trial.
• −Was previously included in this trial.
• −Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → examinations.
• −Is a pregnant or lactating female. Exclude the possibility of pregnancy for women of childbearing potential:
• −Has received or is scheduled for therapeutic intervention (e.g., endovascular therapy, vascular surgery, etc.) of any kind for vascular disease in the arterial territory of interest performed between the 2 MRA procedures or between the study MRAs and the CTA/IADSA procedures when applicable.