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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2009-010968-42-ES |
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Date of registration:
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06/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy evaluation of DOTAREM®-enhanced MRA compared to GADOVIST®–enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases
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Scientific title:
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Efficacy evaluation of DOTAREM®-enhanced MRA compared to GADOVIST®–enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases |
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Date of first enrolment:
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21/10/2009 |
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Target sample size:
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188 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010968-42 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Austria
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France
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Germany
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Italy
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Male or female, aged = 18 years
Patient with chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating lower limb arteriopathy.
Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.
Female of childbearing potential must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or must have a documented negative urine or blood pregnancy test at screening
Patient able to understand and who have provided written informed consent to participate in the trial.
Patient with national health insurance
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:
Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, metallic joint replacement or others according to the imaging laboratory's standard practice).
Patient with known severe adverse drug reaction or contraindication to one of the investigational products (Dotarem® or Gadovist®).
Patient having received any contrast media within 48 hours prior to administration of investigational product for the enhanced-MRA.
Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
Patient who had a major cardiovascular event within 30 days prior to the inclusion.
Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.
Patient having participated in any investigational drug study within 30 days prior the study enrolment.
Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.
Patient under guardianship and/or Inability or unwillingness to cooperate with the requirements of this trial.
Pregnant or breast-feeding patient.
Patients already included in this trial
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patient suffering from abdominal or lower limb arterial diseases
MedDRA version: 9.1
Level: LLT
Classification code 10062585
Term: Peripheral arterial occlusive disease
MedDRA version: 9.1
Level: PT
Classification code 10062585
Term: Peripheral arterial occlusive disease
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Intervention(s)
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Trade Name: Dotarem 0.5mmol/ml
Product Name: Dotarem 0.5mmol/ml, solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadoteric Acid (corresponding to Dota+gadolinium oxide)
CAS Number: 60239-18-1
Other descriptive name: 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
Trade Name: Gadovist 1mmol/ml
Product Name: Gadovist 1mmol/ml, solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadobutrol
CAS Number: 138071-82-6
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number: 1-
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Primary Outcome(s)
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Secondary Objective: To compare diagnostic criteria (Se, Sp, PPV, NPV) of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA using X-Ray Angiography as a gold standard.
To compare DOTAREM®-enhanced MRA versus GADOVIST®-enhanced MRA in terms of :
o artery visualization,
o number of significant stenosis depicted,
o number of technical failures (not assessable segment),
o duration of examination,
o collateral circulation visualization,
o pedal vessel and smaller branches visualization,
o diagnostic confidence
o patient clinical management
o venous overlap
To compare the clinical tolerance (AE) of both contrast media from inclusion and up to the last visit performed.
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Primary end point(s): The primary criterion is the intra patient accuracy (percent agreement) of each type of MRA examination (DOTAREM® or GADOVIST®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography. This criterion will be evaluated at the patient level from the result of site reading. On site readers will be differents and blind from results of the other imaging procedures (MRA and DSA).
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Main Objective: To demonstrate the clinical equivalence (statistical non-inferiority) in terms of global diagnostic performance of DOTAREM®-enhanced MRA as compared to GADOVIST® - enhanced MRA by comparing the degree of agreement at the patient level of each MRA method when using X-Ray Angiography (DSA) as a gold standard.
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Secondary ID(s)
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DGD-44-045
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2009-010968-42-FR
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 13/08/2009
Contact:
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