Kurzfassung

Purpose of this study is to compare the efficacy of angiographic procedures (including the contrast agents used for CE-MRA) as well as the procedural differences and the impact on treatment decisions. By this, a differentiation of the clinical usefulness of the different contrast agents used for MRA and MR angiographic methods as well as the current gold standard procedure XRA shall be achieved.
Phase IIIb, multi-center, intra-individual 3 procedure comparison, independent blinded off-site...Purpose of this study is to compare the efficacy of angiographic procedures (including the contrast agents used for CE-MRA) as well as the procedural differences and the impact on treatment decisions. By this, a differentiation of the clinical usefulness of the different contrast agents used for MRA and MR angiographic methods as well as the current gold standard procedure XRA shall be achieved.
Phase IIIb, multi-center, intra-individual 3 procedure comparison, independent blinded off-site evaluation (consensus of MRA-radiologist, interventional radiologist and vascular surgeon)
Patients who have an indication for the evaluation of the complete run-off arteries (i.e. abdominal aorta from level of renal arteries to pedal arch), i.e. are scheduled for XRA of these arteries; Fontaine-stage IIb – IVEach patient will undergo an XRA, an CE-MRA with gadodiamide and an CE-MRA with MS-325. The order of the exams may differ as the evaluation is independent and off-site and thus carry-over bias is minimized. However, the interval between exams depends on their order as an influence on efficacy or safety evaluations shall be minimized.
If ECCM-MRA is performed first, MS-325 MRA may be performed after 24 h, if MS-325-MRA is performed first, ECCM-325 MRA may be performed after 48 h, XRA may be performed after 24 h after either CE-MRA, however, any CE-MRA may be performed earliest 72 h after XRAPhysical exam: baseline, within 1 h after exam, EOS.

• AE evaluation: During the complete period 24h (+/-4) after exam;
  


• Procedural AEs after XRA (such as complications from arterial access, catheter etc. requiring treatment or hospitalization) for 72h
  


• Vital sign: baseline, within 1 h after exam, EOS.
  


• no Lab (Calcium measurement to be discussed, asked for by Marketing)
  


• no ECG