Intra-individual open-label multicenter comparison study of magnetic resonance angiography (MRA) with the blood pool contrast agent Vasovist® and a conventional extracellular contrast agent with intra-arterial digital subtraction angiography (i.a. DSA) in patients with peripheral artery disease - Comparative study of Vasovist® vs. ECCM in CE-MRA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

Patients who have aortoiliac disease Fontaine-stage IIb – IV and an indication for the evaluation of the infrarenal aorta and the peripheral run-off arteries (i.e. from infrarenal aorta to calves) / Patients who are scheduled for i.a. DSA and MRA of these arteries. I.a. DSA must be planned in a time frame of 1-30 days (preferably 1-7 days, i.e. as close to the Vasovist®-enhanced MRA examination as possible) after the study MRA examination / Patients who have had a contrast-enhanced MRA examination of these arteries using a standard ECCM performed within 1 –7 days prior to the study injection of Vasovist®
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Being less than 18 years of age / Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of Vasovist® / Requiring immediate therapy for their vascular disease (e.g. acute arterial occlusion) or in whom conduct of all three angiographic procedures is not possible / Patients who are scheduled for any therapy between any of the three procedures that interferes with the comparability of the three angiographic procedures / An underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study / Having any physical or mental status that interferes with the informed consent procedure including self-signed consent / ECCM MRA is performed < 24 h prior to Vasovist®-MRA / I.a. DSA is performed within less than 24 h after Vasovist®-MRA / Having received any investigational drug within 30 days prior to entering this study or who are planned to receive any investigational drug during the 24 (+ 4) hour safety follow-up period / Not being able to remain lying down for at least 45 – 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain) / Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents / Presenting with a history of sickle cell disease or other hemolytic anemia / Patients who have received any other contrast medium within 24 hours prior to Vasovist® injection or are scheduled to receive any other contrast medium within the follow-up period / Being clinically unstable and whose clinical course during the 24 (+ 4) hours observation period is unpredictable / Being scheduled for, or likely to require, any surgical intervention within 24 hours before or within the follow-up period / Having any contraindication to MRI examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia) / Patients in whom i.a. DSA is contra-indicated preventing him/her from undergoing standard of reference (SOR) procedure / Having been previously enrolle in this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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