Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NoNO Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1\. A diagnosis of a ruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, or any neuroendovascular technique such as balloon-assisted coiling, stenting, or flowed diversion.
2\. Patient should be Grade II-IV on the WFNS grading scale for SAH.
3\. Male or female with a minimum age of 18 years on the day of enrolment.
4\. Female subjects of childbearing potential: Negative pregnancy test.
5\. Non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing.
6\. Body weight less than or equal to 180 kg.
7\. Vital signs on admission:
* Blood pressure between 80-180 mm Hg systolic/50-100 mm Hg diastolic;
* Body temperature ≤ 38.5C.
8\. Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements.
You may not be if
1\. Prior SAH within 6 months of presentation.
2\. Dissecting or mycotic brain aneurysm.
3\. Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
4\. Known history of life-threatening allergic reaction to any medication.
5\. Chronic renal disease defined as a baseline serum creatinine \> 150 µmol/L.
6\. Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
7\. Women who are breastfeeding.
8\. Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
9\. Pre-morbid (estimated) modified Rankin scale score of \>1.
10\. Previous major stroke.
11\. Patients with known HIV infection.
12\. Participation in a clinical trial with an investigational drug within 30 days preceding this study.
13\. Previous participation in the ENACT trial (e.g, to treat a prior aneurysm), participation in another trial involving NA-1 or prior receipt of NA-1.
14\. Any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 90 days.
