E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient suffering from abdominal or lower limb arterial diseases |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062585 |
E.1.2 | Term | Peripheral arterial occlusive disease |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062585 |
E.1.2 | Term | Peripheral arterial occlusive disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
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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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |