Acute deep vein thrombosis (DVT) MedDRA version: 9.1 Level: LLT Classification code 10051055 Term: Deep vein thrombosis
Conditions
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with recent positive DVT by USCD. 2. Patients who have no contra indication to be screened by MRI 3. Patients who have no contra-indication against the IV injection of Vasovist 4. Patients who have given their fully informed and written consent voluntarily. 5. The subject must be covered by a social security system. 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. Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study 3. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent. 4. If USCD is performed > 48 hours prior to Vasovist®-MRV. 5. 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). 6. Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents. 7. Hypersensitivity to the active substance or to any of the excipients of Vasovist® 8. Being clinically unstable and whose clinical course during the 24 (+ 4) hours observation period is unpredictable. 9. Having any contraindication to MRI examination or specifically for MRV (e.g. pacemaker, recent wound clips, and severe claustrophobia). 10. Renal insufficiency, whatever is the stage. 11. Hepatic insufficiency. 12. The patients having already undergone an injection of Gadolinium. 13. Pregnant women or women breast feeding. 14. Presence of a stent or vascular filter on the examined sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the diagnostic value of Vasovist enhanced MRV in terms of accuracy with regard to USCD scanning used as standard of reference (SOR).;Secondary Objective: Evaluate the sensitivity, specificity and accuracy of Vasovist® enhanced MRV with respect to USCD in (1) all 25 segments, (2) the 6 segments below the knee, (3) in 4 segments in the superficial veins, and (4) in the two legs. In addition the confidence in diagnosis per segment and the proposed patient management per leg (treatment / no treatment required) will be assessed for both MRV and USCD. Safety of Vasovist® enhanced MRV will be assessed in terms of adverse events (AEs) and other safety parameters. ;Primary end point(s): - To determine the accuracy of Vasovist® enhanced MRV with respect to ultra sonography duplex coloured scanning as standard of reference (SOR) for the detection/exclusion of deep veinous thrombosis (DVT) | — |
Countries
France
Outcome results
None listed