Prospective Randomized Open-label Trial to Evaluate risk faCTor management in patients with Unruptured intracranial aneurysms (PROTECT-U)

Intradural saccular unruptured aneurysm

The primary outcome measure will be aneurysm rupture or growth on serial imaging (MR- or CTangiography). Aneurysm growth is defined as an increase in any aneurysm diameter by ≥ 1mm within 36±6 months from randomizantrally by two independent trial radiologists, who will be blinded to the treatment allocation. Events suspicious for SAH but negative CT-imaging will be reviewed centrally by the adjudication committee.

Any growth or rupture of aneurysm during follow-up irrespective of the duration of trial participation, Difference of aneurysm volume (defined as increase of aneurysm volume in computerized measurements from source images by >10% and >3mm3) or aneurysm shape (e.g. development of daughter sac), Development of de novo aneurysm on serial imaging, If a second aneurysm is present: Growth in diameter or volume and alteration of shape of this second aneurysm., Clipping/coiling during the study period, Any ischemic or haemorrhagic stroke, defined as clinical symptoms of stroke AND a compatible lesion on imaging, Myocardial infarction defined as increase of Troponin, CKMB and/or presence of new significant Q waves obtained in ECG, Vascular death (including fatal stroke, fatal myocardial infarction, sudden death), Death from all other causes, Major spontaneous bleeding requiring hospitalisation defined as substantially disabling bleeding, intraocular bleeding leading to the loss of vision, or bleeding necessitating the transfusion of at least 2 units of erythrocyte concentrates, Blood pressure; any data on blood pressure management used, Safety aspects (adverse and serious adverse events, including those mentioned above, see also 8.1.6 and 8.2), Quality of life (as determined by completion of the paper-based EQ-5D-5L form by patient)

No related papers found yet.

Finland, Germany, Netherlands