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). MedDRA version: 7.1 Level: LLT Classification code 10002939
Conditions
Interventions
Product Name: Vasovist
Product Code: MS-325
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadofosveset
CAS Number: 211570-55-7
Current Sponsor code: ZK 00236018
Other descriptive na
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to demonstrate non-inferiority of the diagnostic potential of Vasovist® enhanced MRA as compared to an extracellular contrast medium (ECCM) for detection of infrarenal aorta and/or peripheral artery diseases using intra-arterial digital subtraction angiography (i.a. DSA) as standard of reference (SOR).;Secondary Objective: The secondary objectives are to compare (1) the quantitative assessment and (2) the qualitative assessment of arterial stenosis/disease during first pass and steady state (SS) as compared to SOR. In addition, the quantitative assessment of vessel enhancement, the qualitative assessment of disease, the qualitative assessment of plaque morphology and the quality of vascular anatomy will be evaluated. Furthermore, the delineation of vessel wall, the venous enhancement and the diagnostic potential of venous enhancement will be assessed. In addition, to demonstrate safety of Vasovist®-enhanced MRA.;Primary end point(s): Non-inferiority of the diagnostic potential of Vasovist® enhanced MRA. | — |
Countries
Austria, Germany
Outcome results
None listed