E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
peripheral arterial disease |
arteriopatia obliterante periferica |
|
E.1.1.1 | Medical condition in easily understood language |
obstructive atherosclerosis of leg arteries |
aterosclerosi ostruttiva delle arterie degli arti inferiori |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 |
The aim of this study will be to evaluate the benefit of the administration of ticagrelor on intermediate endpoints of efficacy (% of neointimal volume obstruction) and safety (percentage of uncovered stent struts) assessed by Frequency Domain-Optical Coherence Tomography in patients with symptomatic femoropopliteal disease, mainly presenting with critical limb ischemia, and treated with angioplasty and implantation of paclitaxel-eluting stent(s). |
Scopo di questo studio è valutare nei pazienti sottoposti ad impianto di stent a rilascio di paclitaxel (Zilver PTX, Cook Medical), il beneficio di ticagrelor vs clopidogrel nel trattamento della patologia steno-occlusiva della femorale superficiale e poplitea in termini di efficacia antiaggregante e di effetto a carico del tratto di vaso stentato (volume di neointima) e sicurezza (% di struts non ricoperti e presenza di malapposizione) all'analisi con FD-OCT. |
|
E.2.2 | Secondary objectives of the trial |
Secondary endpoints will be 1) platelet function assay (using VerifyNow system) before intervention, at 24 hours, and at 1, 3,and 12 months 2) eventual presence; maximal area and total volume of instent thrombus, at baseline and follow-up 3) strut-level neointimal thickness 4) post-intervention and follow-up tissue prolapse and dissection 5) % of acute, persisting and newly acquired malapposed struts. Correlative studies between PRU and % net volume obstruction, % uncovered stent struts, and total thrombus area will be performed. A dedicated subanalysis will be performed in the stent overlap areas |
gli obiettivi secondari comprendono le seguenti valutazioni: la risposta alla terapia antiaggregante misurata con VerifyNow prima della rivascolarizzazione, a 24 ore e a 1, 3 e 12 mesi; la presenza o meno di materiale trombotico intrastent subito dopo l’impianto dello stent e al follow-up e sua eventuale area massima e volume totale; il SIT; la presenza di prolasso di placca e dissezione post-PTA e al follow-up; la percentuale di struts malapposti (acuti, persistenti e di nuovo riscontro, preesistenti e di nuovo riscontro). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age > 18 years, with clinical evidence of claudication or critical limb ischemia; angiographic evidence of > 50% stenosis or occlusion of the superficial femoral or popliteal artery for a length > 40mm; presence of at least 1 vessel with direct flow to the pedal circle; treated with drug eluting stent implantation |
I pazienti arruolabili allo studio devono avere almeno una età > 18 anni, con evidenza clinica di claudicatio o ischemia critica dell’arto con evidenza angiografica di stenosi >50% o occlusione dell’arteria femorale superficiale o poplitea per una lunghezza >40mm, la presenza di almeno 1 vaso di gamba con flusso diretto al circolo pedale, sottoposti ad impianto di stent medicato |
|
E.4 | Principal exclusion criteria |
need of major limb amputation for irreversibility of the lesions (judged by diabetic foot specialist); hypersensitivity or known contraindications to aspirin, heparin, ticagrelor or paclitaxel or any of the excipients; known hypersensitivity to iodinated contrast media that cannot be adequately controlled by premedication; unwillingness to carry out clinical and angiographic controls; patients with a medical condition requiring treatment with cytostatic drugs or radiation therapy with a life expectancy of less than 1 year; active pathological bleeding, history of intracranial haemorrhage and severe hepatic failure; pregnancy or lactation; dialysis required. |
La necessità di amputazione d’arto per l’irreversibilità delle lesioni (giudizio dello specialista del piede diabetico); ipersensibilità o controindicazioni note ad aspirina, eparina, clopidogrel, ticagrelor o paclitaxel; ipersensibilità nota ai mezzi di contrasto iodati che non possa essere controllata adeguatamente dalla premedicazione specifica; la non volontà dichiarata di eseguire i controlli clinici ed angiografici stabiliti dallo studio. Verranno inoltre esclusi dallo studio pazienti con patologie che necessitano di trattamenti con farmaci citostatici o con terapia radiante o che comunque abbiano una aspettativa di vita di meno di 1 anno. |
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E.5 End points |
E.5.1 | Primary end point(s) |
net percentage volume obstruction assessed by Frequency-Domain -Optical Coherence Tomography |
ostruzione percentuale del volume di neointima misurata con FD-OCT a 12 mesi, quale indicatore dell’entità di proliferazione neointimale. Endpoint co-primario di sicurezza sarà la percentuale degli struts non ricoperti. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) platelet function assay (using VerifyNow system) before intervention, at 24 hours, and at 1, 3,and 12 months 2) eventual presence; maximal area and total volume of instent thrombus, at baseline and follow-up 3) strut-level neointimal thickness 4) post-intervention and follow-up tissue prolapse and dissection 5) % of acute, persisting and newly acquired malapposed struts. Correlative studies between PRU and % net volume obstruction, % uncovered stent struts, and total thrombus area will be performed. A dedicated subanalysis will be performed in the stent overlap areas |
risposta alla terapia antiaggregante misurata con VerifyNow prima della rivascolarizzazione, a 24 ore e a 1, 3 e 12 mesi; presenza o meno di materiale trombotico intrastent subito dopo l’impianto dello stent e al follow-up e sua eventuale area massima e volume totale; il SIT; la presenza di prolasso di placca e dissezione post-PTA e al follow-up; la percentuale di struts malapposti (acuti, persistenti e di nuovo riscontro, preesistenti e di nuovo riscontro). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
studio pilota monocentrico |
monocentric pilot study |
|
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 | Yes |
E.8.2.3.1 | Comparator description |
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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.8.5 | 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 | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |