NEWS HIGHLIGHTS
Published Studies Related to Vasovist (Gadofosveset)
Contrast-enhanced whole-heart MR coronary angiography at 3.0 T using the intravascular contrast agent gadofosveset. [2009.07]
OBJECTIVES: The purpose of this study was to compare contrast-enhanced (CE) whole-heart coronary magnetic resonance angiography (MRA) at 3.0 T using gadofosveset to noncontrast-enhanced steady-state free precession (SSFP) coronary MRA at 1.5 T... CONCLUSIONS: CE whole-heart coronary MRA at 3.0 T demonstrated higher overall CNR between coronary blood and myocardium and an improved image quality of the distal coronary segments compared with noncontrast-enhanced SSFP coronary MRA at 1.5 T.
Safety and efficacy of gadofosveset-enhanced MR angiography for evaluation of pedal arterial disease: multicenter comparative phase 3 study. [2008.01]
CONCLUSION: Because of markedly better efficacy than no contrast agent and a minimal and transient side-effect profile, 0.03 mmol/kg of gadofosveset was found safe and effective for MR angiography of patients with pedal arterial disease.
Thoracic and abdominal MRA with gadofosveset: influence of injection rate on vessel signal and image quality. [2009.08]
The purpose of this study was to investigate the influence of different injection rates on the maximum signal intensity and the arterio-venous transit time of dynamic gadofosveset-enhanced first pass MR angiography (MRA). Twenty-one healthy male volunteers were examined with a time-resolved echo-shared MRA at 1.5 T...
Gadofosveset-enhanced MR angiography of carotid arteries: does steady-state imaging improve accuracy of first-pass imaging? Comparison with selective digital subtraction angiography. [2009.05]
PURPOSE: To evaluate the diagnostic accuracy of gadofosveset-enhanced magnetic resonance (MR) angiography in the assessment of carotid artery stenosis, with digital subtraction angiography (DSA) as the reference standard, and to determine the value of reading first-pass, steady-state, and "combined" (first-pass plus steady-state) MR angiograms... CONCLUSION: Gadofosveset-enhanced MR angiography is a promising technique for imaging carotid artery stenosis. Steady-state image reading is superior to first-pass image reading, but the combined reading protocol is more accurate.
A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease. [2008.02]
PURPOSE: To determine prospectively the safety and efficacy of the blood-pool contrast agent gadofosveset trisodium in renal artery magnetic resonance angiography (MRA)... CONCLUSION: In patients with known or suspected renal arterial disease, multi-phase gadofosveset-enhanced MRA significantly improves sensitivity, specificity, and accuracy versus non-enhanced MRA. Gadofosveset was safe and well tolerated in this patient population.
Clinical Trials Related to Vasovist (Gadofosveset)
Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease [Recruiting]
This study aims at investigating the diagnostic accuracy of magnetic resonance angiography
using the contrast agent Vasovist® in the detection of relevant vascular narrowing of the
lower extremity. Patients who have been scheduled for intra-arterial conventional
angiography are eligible for this trial.
Improved Diagnosis of Congenital Heart Disease by Magnetic Resonance Imaging Using Vasovist [Recruiting]
Magnetic Resonance Imaging (MRI) is an effective and radiation free method of diagnosing
Congenital Heart Disease (CHD). MRI works by taking images of the anatomy and physiology.
These images also provide information on the hearts function and blood flow. The clarity of
these images is enhanced by the use of contrast agents (dyes). However these agents only
stay in the blood vessels for a short time and therefore limit the time in which the better
quality images can be obtained. This study aims to determine whether MRI using Vasovist (a
dye that stays in the vessels for a prolonged period of time) can improve the diagnosis of
Congenital Heart Disease (CHD) by allowing more areas to be imaged and the improved
assessment of various parameters (anatomy, volumes, flow) as well as vastly improving image
quality.
Whole Body Magnetic Resonance Angiography in Ischemic Patients [Recruiting]
To investigate the diagnostic performance of whole body magnetic resonance angiography
(WB-MRA) using two different magnetic resonance contrast agents.
Ultrasound Accelerated Catheter-directed Thrombolysis in Primary Ilio-Femoral Deep Venous Thrombosis [Not yet recruiting]
Rationale: Iliofemoral deep venous thrombosis (IFDVT) is associated with significant post
thrombotic morbidity. The presence of both obstruction and reflux significantly increases
the chances for development of post-thrombotic syndrome (PTS). Early thrombolysis may reduce
the incidence of PTS as compared to treatment with conventional anticoagulant medication
alone. Improvement of the health related quality of life (HRQOL) has been reported after
surgical clot removal. The investigators hypothesize that such improvements could also be
reached after catheter directed thrombolysis.
Objective: To assess whether catheter directed thrombolytic therapy for the treatment of
IFDVT can safely and effectively reduce post thrombotic morbidity after one year. The
secondary objective is to study whether catheter directed thrombolytic intervention has a
positive effect on the quality of life of patients with IFDVT and to assess late PTS.
Study design: prospective, non blinded, randomized, controlled, multicenter, intervention
study Study population: The study population includes all consecutive patients with IFDVT
presenting at the emergency or outpatient departments of the participating centres. The
thrombus should not be older than 14 days at randomization.
Intervention: After randomization patients will be allocated to either conservative
anticoagulant treatment or to catheter directed thrombolysis combined with conservative
anticoagulant treatment.
Main study parameters/endpoints: The primary efficacy outcome is the incidence of PTS at one
year; a decline in PTS incidence from 25% to 8% is anticipated. The secondary outcome is the
Health related Quality of life and late PTS during follow-up. The principal safety outcome
is major bleeding during anticoagulant therapy. Bleeding as well as events of recurrent
thrombosis will be monitored. The patency of the venous system of the affected lower limb
will be assessed as well as the percentage of clot lysis, after thrombolytic intervention.
Additionally, measurements of markers of coagulation and inflammation will be performed
during follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: For patients who are randomized to the intervention arm of the study a hospital
stay for 24-36 hour is mandatory during catheter directed thrombolysis. All patients will
undergo additional imaging by MRA-vasovist and air phletysmography (APG) at baseline and
after 12 months. Clinical follow-up visits will be matching usual care at 3, 6, 12 months;
blood will be taken at these visits. Health-related quality of life (HRQOL) questionnaires
will be filled out by all patients at baseline, 3, 6 and 12 months after the event; and once
a year during the entire study duration. Further treatment will be in accordance with
current guidelines for antithrombotic treatment. There may be an enhanced risk of bleeding
in the thrombolysis group. The expected benefit is reduction of PTS from 25% to 8%, together
with an improved quality of life.
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