E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with aortic aneurism who underwent to endovascular repair of aortic aneurism. |
Pazienti con aneurisma dell'aorta addominale sottoposti a endoprotesi vascolare. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with aortic aneurism who underwent to endovascular repair of aortic aneurism. |
Pazienti con aneurisma dell'aorta addominale sottoposti a endoprotesi vascolare. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000051 |
E.1.2 | Term | Abdominal aneurysm |
E.1.2 | System Organ Class | 100000004866 |
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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 evaluate the quality and thaaccuracy of angiography with compuetr tomography (CTA) using low dose of contrast and low dose of radiation. |
Valutare la qualit¿ e l¿accuratezza diagnostica di un protocollo di angiografia con tomografia computerizzata (CTA) con bassa dose di chilovoltaggio (kV) e con bassa dose di mezzo di contrasto in pazienti in follow-up per endoprotesi vascolare per il trattamento dell¿aneurisma dell¿aorta addominale (EVAR). |
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E.2.2 | Secondary objectives of the trial |
1. Evaluation of subjective qualitative and quantitative analysis with low dose protocol compare to the standard. 2. Evaluation of diagnostic accuracy of low dose protocol. 3.Evaluation of dose reduction in low dose protocol. |
1: Valutare soggettivamente e qualitativamente la qualit¿ dell'immagine di CTA acquisite con bassa dose (80 -100 kV e 50 mL mezzo di contrasto) confrontata con quelle acquisite a dose standard (120 kV e 80 mL mezzo di contrasto) in pazienti in follow-up per EVAR. 2: Valutare l¿accuratezza diagnostica delle TCA a bassa dose in pazienti in follow-up per EVAR. L¿accuratezza diagnostica sar¿ valutata in comparazione con le CTA acquisite a dose standard e se disponibili con altre metodiche quali l¿angiografia con sottrazione digitale (DSA) e/o l¿angiografia con risonanza magnetica (RMA). 3: Valutare la riduzione di dose radiante del protocollo a bassa dose rispetto a quella a dose standard.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Patients in follow-up for EVAR Patient with EVAR waiting for re-procedure |
I criteri di inclusione nella popolazione d’esame sono: Pazienti in follow-up per EVAR Pazienti con EVAR in attesa di re-intervento |
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E.4 | Principal exclusion criteria |
Esclusion criteria: Allergy to contrast media Pregnancy |
I criteri di esclusione nella popolazione d’esame sono: Allergia nota al mezzo di contrasto Gravidanza |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the quality and thaaccuracy of angiography with compuetr tomography (CTA) using low dose of contrast and low dose of radiation. |
Valutare la qualità e l’accuratezza diagnostica di un protocollo di angiografia con tomografia computerizzata (CTA) con bassa dose di chilovoltaggio (kV) e con bassa dose di mezzo di contrasto in pazienti in follow-up per endoprotesi vascolare per il trattamento dell’aneurisma dell’aorta addominale (EVAR). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Evaluation of subjective qualitative and quantitative analysis with low dose protocol compare to the standard. 2. Evaluation of diagnostic accuracy of low dose protocol. 3.Evaluation of dose reduction in low dose protocol. |
1: Valutare soggettivamente e qualitativamente la qualit¿ dell'immagine di CTA acquisite con bassa dose (80 -100 kV e 50 mL mezzo di contrasto) confrontata con quelle acquisite a dose standard (120 kV e 80 mL mezzo di contrasto) in pazienti in follow-up per EVAR. 2: Valutare l¿accuratezza diagnostica delle TCA a bassa dose in pazienti in follow-up per EVAR. L¿accuratezza diagnostica sar¿ valutata in comparazione con le CTA acquisite a dose standard e se disponibili con altre metodiche quali l¿angiografia con sottrazione digitale (DSA) e/o l¿angiografia con risonanza magnetica (RMA). 3: Valutare la riduzione di dose radiante del protocollo a bassa dose rispetto a quella a dose standard. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |