E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III |
|
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 |
|
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 |
|
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 assess the clinical equivalence of the diagnostic performance of DOTAREM®-enhanced MRA as compared to GADOVIST® - enhanced MRA by comparing the arterial visualization of vessels from the abdominal aorta to pedal artery. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of the trial are:
To compare DOTAREM®-enhanced MRA versus GADOVIST®-enhanced MRA in term of: - number of assessable segments - number of significant stenosis depicted, - image quality of the collateral circulation, - image quality of pedal vessel and smaller branches - diagnostic confidence - patient clinical management - venous overlap - duration of the procedure - signal intensity
To compare the clinical tolerance of both contrast media during and up to 24 hours after each MRA examination.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female or male , aged ≥ 18 years Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III. Female of childbearing potential must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilized, or post-menopausal (minimum 12months of amenorrhea) or must have a documented negative urine or blood pregnancy test at screening Patients having provided their written informed consent to participate in the trial Patients with national health insurance
|
|
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). Patients with severely impaired renal function with a eGFR (MDRD) < 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days). Patient with known severe adverse drug reaction or contraindication to one of the investigational products. 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 the vessels of interest between the two MRA procedure. Patient who had a major cardiovascular event within 30 days prior to the inclusion. 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 Patients included in another clinical trial involving an Investigational Medicinal Product (IMP)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary criterion is the overall image quality of each MRA examination. Image quality will be assessed on a 5-point scale: (1) Excellent: allows delineation of the artery wall, visualization of the sub-segments and additional information other than arterial stenosis (e.g. accessory arteries, collateral circulation etc). (2) More than adequate: allows delineation of the artery wall and visualization of the sub-segments. (3) Adequate: allows the arteries and the sub-segments visualization (thus, allow the quantitative evaluation of a possible stenosis). (4) Less than adequate: allows potential stenosis visualization, but quantitative assessment is not possible along the entire main artery. (5) Non-diagnostic: does not allow the artery to be assessed in terms of presence or absence of stenosis.
|
|
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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
|
The end of the trial will be 24hours after the last contrast media-enhanced MRA (last imaging procedure) - A phone call interview will be performed for the end of the study (at 24hours after the last imaging procedure). |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |