Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI
Male or female patients 18 years of age or older willing to participate in the trial and follow all study procedures specified in the protocol.
Patient having read the information in the ICF and having provided his/her consent to participate in writing by dating and signing the ICF prior to any trial related procedure being conducted.
clinical signs and symptoms including but not limited to prior stroke, transient ischemic attack (TIA), amaurosis fugax (transient monocular blindness) and/or previous diagnostic tests (CTA, IA-DSA, or ultrasound) or
symptoms of lower-extremity arterial disease (stages II-IV according to the Leriche-Fontaine classification, or 1 to 6 according to Rutherford classification 113 and/or confirmed by previous imaging (Doppler ultrasound, CTA, MRA, IADSA) or
by testing on site 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 any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.
Guerbet
Lead sponsor
Bracco Imaging S.p.A.
Collaborator