E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with diagnosis of lower limbs PAOD, ranging from stage 2 to 5 according to Rutherford classification and lesions of the SFA treated by endovascular revascularization |
PAZIENTI AFFETTI DA ARTERIOPATIA OBLITERANTE CRONICA PERIFIERICA (AOCP) STADIO 2-5 SECONDO RUTHERFORD SOTTOPOSTI A RIVASCOLARIZZAZIONE ENDOVASCOLARE DELL'ARTERIA FEMORALE SUPERFICIALE |
|
E.1.1.1 | Medical condition in easily understood language |
PATIENTS WITH LOWER LIMBS ISCHEMIA TREATED BY ENDOVASCULAR REVASCULARIZATION |
ISCHEMIA DEGLI ARTI INFERIORI TRATTATI CON PROCEDURA ENDOVASCOLARE A LIVELLO DELLA FEMORALE SUPERFICIALE |
|
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 | 10016430 |
E.1.2 | Term | Femoral artery stenosis |
E.1.2 | System Organ Class | 100000004866 |
|
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 and quantify the efficacy of benefits in terms of patency rate of the target lesion (Late Lumen Loss) 3, 6 and 12 months after the procedure of revascularization across the two branches |
valutare e quantificare l'efficacia di benefici in termini di tasso di pervietà della lesione target misurato in termini di Late Lumen Loss a 3, 6 e 12 mesi dalla procedura di rivascolarizzazione tra i due bracci |
|
E.2.2 | Secondary objectives of the trial |
To assess and compare the rate of adverse events (bleeding) related to DAPT with the short regime as compared with the prolonged regime. (b) To assess and compare the need of Target Lesion Revascularization at 3, 6 and 12 months. (c) To quantify and compare the major amputation-free survival at 12 months |
valutare e confrontare la frequenza di eventi avversi (sanguinamento) correlati a doppia terapia antiaggregante di durata 3 mesi rispetto a durata 1 mese; (b) valutare e confrontare la necessita' di una rivascolarizzazione della lesione target a 3, 6 e 12 mesi; (c) quantificare e confrontare la sopravvivena libera da amputazione maggiore a 12 mesi |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Have given written informed consent to participate • Be aged 18 years and over • Be affected by lower limbs PAOD staged 2-5 according to Rutherford classification and lesions of the SFA • Have undergone a successful endovascular revascularization of the SFA as documented by the intra-operative angiography
|
-Firma del consenso informato -Età > 18 anni -Diagnosi di AOCP arti inferiori in stadio 2-5 secondo la classificazione di Rutherford e lesione dell’arteria femorale superficiale lesione dell'arteria femorale superficiale trattata mediante rivascolarizzazione endovascolare con successo documentato da angiografia intraoperatoria |
|
E.4 | Principal exclusion criteria |
-Life expectancy < 12 months -Contraindication to DAPT or ASA/clopidogrel assumption (Hypersensitivity to the basic principle or excipients, history of acute asthma or angioneurotic edema associated with drug assumption, peptic ulcer and/or gastro-intestinal haemorrhage in acute phase or in medical records, or other kinds of haemorrhage (e.g. cerebrovascular bleeding), haemorrhagic diathesis, haemostasis disturbances (e.g. Thrombocytopenia or haemophilia), severe cardiac failure, severe liver failure, severe CKF (GFR<30ml/h), therapy with methotrexate at dosage > 15 mg per week) -Participants to a clinical trial consisting in administration of an experimental drug within 30 days or 5 half-lives of the drug under investigation. -Patients under anticoagulant therapy -History of allergies to ASA and/or clopidogrel -Lack of written informed consent by the patients -Unwillingness, impossibility or incapability to respect the study protocol for any reason -CKF under haemodialytic treatment, because it can affect the patency rate of the lumen bias the results on such a small-sized sample) -Pregnant women
|
-Aspettativa di vita <12 mesi -Allergia ad ASA o clopidogrel -Controindicazioni a doppia antiaggregazione (Ipersensibilità a principi attivi ed eccipienti, Storia di asma acuto o edema angioneurotico da assunzione di farmaco, ulcera peptica e/o emorragia gastroenterica in fase acuta pregressa o attuale, diatesi emorragica, disturbi dell’emostasi, scompenso cardiaco grave, insufficienza epatica grave, insufficienza renale terminale (GFR <30 ml/h), terapia con metotrexate a dosaggio>15 mg/settimana) -Insufficienza renale cronica in trattamento emodialitico -Pazienti in terapia anticoagulante -Mancanza del consenso informato alla partecipazione allo studio -Donne in gravidanza -Partecipazione ad uno studio clinico in cui è stato somministrato un farmaco sperimentale entro 30 giorni o 5 emivite del farmaco in studio. -Mancata disponibilità o capacità di rispettare il protocollo di studio per un qualsiasi motivo.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Late Lumen Loss (LLL), defined as difference between the lumen diameter of the target artery measured right after the procedure of revascularization and after 3, 6 and 12 months |
Late Lumen Loss (LLL) definito come differenza tra il diametro del lume dell'arteria target misurato subito dopo la procedura di rivascolarizzazione e dopo 3, 6 e 12 mesi |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after the procedure di revascularization and after 3, 6 and 12 months |
subito dopo la procedura di rivascolarizzazione e dopo 3, 6 e 12 mesi |
|
E.5.2 | Secondary end point(s) |
(a). Prevalence of bleeding episodes. (b) Need of Target Lesion Revascularization (TLR) assessed 3, 6 and 12 months after the revascularization. The expected value of TLR after 12 months from the literature analysis is 25%. (c) Major amputation-free survival at 12 months after the revascularization (expected value: 85-90%) |
(a) prevalenza degli episodi di sanguinamento (b) necessità di rivascolarizzazione della lesione target misurata dopo 3, 6 e 12 mesi dalla rivascolarizzazione Il valore atteso di rivascolarizzazione della lesione target è il 25%, da un'analisi della letteratura (c) tasso di sopravvivenza libera da amputazione maggiore a 12 mesi dalla rivascolarizzazione (valore atteso: 85-90%) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
(b) 3, 6 and 12 months after the rivascularization (c) 12 months after the rivascularization |
(b) 3, 6 e 12 mesi dalla rivascolarizzazione (c) 12 mesi dalla rivascolarizzazione |
|
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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
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 |
valutatore in cieco |
Blind evaluator |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
trattamento di durata 3 mesi versus 1 mese |
3 months treatment vs 1 month treatment |
|
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.8.6 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 | Yes |
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 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |