Vasovist in MRI follow-up of embolized intracranial aneurysms at 3 Tesla – A prospective, multicenter, multinational, open-label, investigator initiated study - Vasovist in intracranial aneurysms

• Conditions: Patients with intracranial aneurysm after coil embolization with suspicion of residual blood flow; MedDRA version: 9.1Level: LLTClassification code 10002337Term: Aneurysm intracranial

• Registration Number: EUCTR2008-003670-18-DE
• Lead Sponsor: Deutsches Krebsforschungszentrum Stiftung des öffentlichen Rechts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients who underwent an endovascular embolization of an intracranial aneurysm
using Guglielmi detachable coils (GDC) in the past
2.Suspected of presenting with residual blood flow in the treated aneurysm
3.Scheduled for a follow-up i.a. DSA for clinical reasons
4.At least 30 days between treatment of the aneurysm and inclusion into this study
5.Willing to undergo the study MRA procedure with Vasovist within a time interval of a
minimum of 2 hours and a maximum of 7 days of i.a. DSA
6.Willing to comply with the study procedures
7.Patients who have given their fully informed and written consent voluntarily

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

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.Having an underlying disease or concomitant medication which may interfere with
efficacy or safety evaluations as planned in this study
4.Having any physical or mental status that interferes with the informed consent
procedure including self-signed consent
5.GFR < 60ml/m²/1.73m² (MDRD), values =1 week; or patients on hemodialysis
6.Renal or liver transplant patients, including patients with scheduled liver
transplant are excluded due to the potential risk for nephrogenic systemic fibrosis
(NSF)
7.Patients with known severe cardiac arrhythmia
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.Having received any investigational drug within 7 days prior to entering this
study or who are planned to receive any investigational drug during the 2 hours
adverse event monitoring period.
12.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).
13.Being clinically unstable and whose clinical course during the 2 hours adverse
event monitoring period is unpredictable
14.Being scheduled for, or likely to require, any surgical intervention within 2 hours
before or within the adverse event monitoring period
15.Patients in whom i.a. DSA is contra-indicated preventing him/her from
undergoing standard of reference (SOR) procedure
16.Close affiliation with the investigational site; e.g. a close relative of the
investigator
17.Having been previously enrolled in this study
18.Participating in another clinical trial
19.Having been treated using ev3 nexus coils

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified