Patients with intracranial aneurysm after coil embolization with suspicion of residual blood flow MedDRA version: 9.1 Level: LLT Classification code 10002337 Term: Aneurysm intracranial
Conditions
Interventions
Trade Name: Vasovist®
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Gadofosveset Trisodium
CAS Number: 211570-55-7
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration
Sponsors
Deutsches Krebsforschungszentrum Stiftung des öffentlichen Rechts
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the superior sensitivity of Vasovist-enhanced MRI at 3T in the detection of residual blood flow in treated aneurysms in comparison to TOF MRI using DSA as the SOR;Secondary Objective: •To assess the diagnostic value of Vasovist-enhanced MRI at 3T in comparison to native 3D time-of-flight (TOF) MRI with DSA as the SOR •To assess the diagnostic value of Vasovist-enhanced MRI at 3T in comparison to native 3D time-of-flight (TOF) MRI using DSA and a truth panel assessment as the SOR •To assess the diagnostic value of time-resolved (dynamic) first pass Vasovist-enhanced MRA in comparison to the combined assessment of dynamic Vasovist-enhanced MRA and high spatial resolution steady state MRA •To assess the overall diagnostic image quality and diagnostic confidence •To assess the impact on the proposed therapeutic strategy •To assess interobserver agreement ;Primary end point(s): Detection of residual blood flow in the treated aneurysm (including aneurysm neck and aneurysm dome, classification of Raymond et al., 2003) – dynamic and steady state Vasovist-enhanced MRA vs. TOF MRI using i.a. DSA as the SOR | — |
Countries
Germany
Outcome results
None listed