E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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). |
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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 | 10002939 |
E.1.2 | Term | Aortoiliac 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 |
- Accuracy of quantitative stenosis grading (<50%, >=50%) of Vasovist enhanced MRA with regard to i.a. DSA as standard of reference (SOR). |
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E.2.2 | Secondary objectives of the trial |
- Proportion of correct stenosis gradings (<50%, 50-99%, occlusion) of Vasovist® enhanced MRA compared to DSA - Sensitivity and specificity (<50%, >=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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 Vasovistīĸ injection). 5. Patients who have given their fully informed and written consent voluntarily.
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E.4 | Principal 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 < 30ml/m²/1.73m² (MDRD), values ≤ 1 week or patients on hemodialysis 7. Renal or liver transplant patients, including patients with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF). 8. MR contraindications (pacemaker, magnetic clips, severe claustrophobia) 9. Known allergy to Gadofosveset 10.Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents. 11.Untreated significant stenosis in pelvis 12.Known severe coagulopathy (PTT >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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the accuracy of quantitative stenosis grading (<50%, >=50%) of Vasovist enhanced MRA with regard to i.a. DSA as SOR.
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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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The end of the trial is the last visit of the last patient. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |