Determination of Diagnostic Accuracy and Added Value of Vasovist®-Enhanced Peripheral MRA in Comparison to Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients with Peripheral Artery Disease

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Patients who have Fontaine-stage III and IV and an indication for therapeutic i.a. DSA
2. PAOD has to be confirmed by ECCM MRA, CTA, non-selective DSA, Doppler ultrasound (DUS) prior to the study.
3. Patients who are willing to undergo the study MRA procedure with Vasovist*.
4. Patients who are willing to comply with the study procedures (e.g. being followed-up for 12 hours after the Vasovist* injection).
5. Patients who have given their fully informed and written consent voluntarily.

Exclusion Criteria

1. Being less than 18 years of age.
2. 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*. The manufacturer*s instructions for performing the urinary pregnancy test are to be followed.
3. Patients who are scheduled for any therapy between any of the two procedures (MRA and DSA) that interferes with the comparability of the two angiographic procedures.
4. Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
5. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
6. GFR < 30ml/m²/1.73m² (MDRD), values <= 1 week or patients on hemodialysis
7. Renal or liver transplant patients, including patients with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF).
8. MR contraindications (pacemaker, magnetic clips, severe claustrophobia)
9. Known allergy to Gadofosveset
10. Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
11. Untreated significant stenosis in pelvis
12. Known severe coagulopathy (PTT >25s, Quick < 60%)
13. Having received any investigational drug within 7 days prior to entering this study or who are planned to receive any investigational drug during the safety follow-up period.
14. Not being able to remain lying down for at least 30-45min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
15. Being clinically unstable and whose clinical course during the 12 hours observation period is unpredictable.
16. Being scheduled for, or likely to require, any surgical intervention within 12 hours before or within the follow-up period.
17. Patients in whom i.a. DSA is contra-indicated preventing him/her from undergoing standard of reference (SOR) procedure.
18. Close affiliation with the investigational site; e.g. a close relative of the investigator.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study will be conducted to determine the diagnostic accuracy of Vasovist*<br /><br>enhanced MRA in stenosis grading (<50%, >=50%) with regard to DSA as SOR for<br /><br>the defined segments. To have a sufficient prevalence of stenotic lesions all<br /><br>patients in this study have to be scheduled for therapeutic DSA of one leg.</p><br>

Secondary Outcome Measures

Name	Time	Method

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