Efficacy evaluation of DOTAREM-enhanced MRA compared to GADOVIST-enhanced MRA in the diagnosis of clinical significant abdominal or lower limb arterial diseases - ND

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2009-010968-42-IT
• Date of registration: 20/07/2009
• Prospective Registration: Yes
• Primary sponsor: GUERBET
• Public title: Efficacy evaluation of DOTAREM-enhanced MRA compared to GADOVIST-enhanced MRA in the diagnosis of clinical significant abdominal or lower limb arterial diseases - ND
• Scientific title: Efficacy evaluation of DOTAREM-enhanced MRA compared to GADOVIST-enhanced MRA in the diagnosis of clinical significant abdominal or lower limb arterial diseases - ND
• Date of first enrolment: 25/08/2009
• Target sample size: 188
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010968-42
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Austria, France, Germany, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
Male or female, aged > or = 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 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). Patients 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 assesment 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

Health Condition(s) or Problem(s) studied

Patients suffering from abdominal or lower limb arterial diseases
MedDRA version: 12.0 Level: LLT Classification code 10062585 Term: Peripheral arterial occlusive disease

Intervention(s)

Trade Name: DOTAREM*INFUS 15ML 0,5MMOL/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ACIDO GADOTERICO
CAS Number: 72573-82-1
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 4.1898-

Trade Name: GADOVIST*FL 15ML 1,0MMOL/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadobutrol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9070.8-

Primary Outcome(s)

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 blind from results of the evaluation of the other imaging procedure (MRA or DSA).

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: - artery visualization - significant stenosis depicted - non assessable segment (technical failures) - duration of examination - collateral circulation visualization - pedal vessel and smaller branches visualization - diagnostic confidence - patient clinical management - venous overlap. To compare the clinical tolerance (AE) of both contrast media from inclusion and up to the last visit performed

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

Secondary ID(s)

2009-010968-42-FR

DGD-44-045