Patients suffering from PAOD stage III or stage IV (confirmed by ECCM MRA, CTA, non-selective DSA, DUS) and have an indication for the evaluation of the entire lower leg axis down to the feet (common femoral artery to the arteries of the foot) by therapeutic digital subtraction angiography (DSA). MedDRA version: 9.1 Level: LLT Classification code 10002939 Term: Aortoiliac occlusive disease
Conditions
Interventions
Trade Name: Vasovist
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadofosveset Trinatriumsalz
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentr
Sponsors
University Heidelberg, University Hospital Mannheim
Eligibility
Sex/Gender
All
Inclusion criteria
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, digital ultra¬sound (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. 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. Patients who are scheduled for any therapy between any of the two procedures that in¬terferes 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 proce¬dure including self-signed consent. 6. GFR 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 pe¬riod. 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 be¬fore 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Accuracy of quantitative stenosis grading (=50%) of Vasovist enhanced MRA with regard to i.a. DSA as standard of reference (SOR).;Secondary Objective: - Proportion of correct stenosis gradings (=50%) of Vasovist enhanced MRA compared to DSA - Length of stenosis (target) of Vasovist® enhanced MRA compared to DSA - Correlation of the description of the inflow, target, outflow of Vasovist® enhanced MRA (combined) compared to DSA [what is target lesion?] - Number of patients with change of therapeutic approach after reviewing Vasovist enhanced MRA compared to initial non-invasive angiography (MRA, CTA, US) - Diagnostic value (detection of target lesion y/n) of time-resolved first pass MRA in comparison to high-spatial resolution steady state MRA - Additional venous pathologies: thrombus, superficial vein thrombosis, venous aneurysms, varicosis - Diagnostic confidence of Vasovist enhanced MRA and DSA ;Primary end point(s): The primary endpoint is the accuracy of quantitative stenosis grading (=50%) of Vasovist enhanced MRA with regard to i.a. DSA as SOR. | — |
Countries
Germany, Netherlands
Outcome results
None listed