Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-24 @ 8:01 PM
NCT ID:
NCT02259504
Eligibility Criteria:
Inclusion Criteria
Candidates for this Study must meet all of the following criteria to be enrolled in the Study:
1. Subject age ≥ 18 and ≤ 80 with a diagnosis of ruptured or unruptured saccular intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion
2. Aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen, and including any thrombosed portions\] ≤ 4.9 mm
3. If ruptured aneurysm: Hunt and Hess 0-3
4. If unruptured aneurysm: Subject grade Modified Rankin Scale mRS 0 - 2 The investigator believes the aneurysm is appropriate for the designated Phase coiling paradigm. (Phase 1: Frame, fill and finish with MicroVention HyperSoft® 3D and/or HyperSoft® Helical coils). The operator at his discretion may frame with any bare metal framing coil but the remainder of the coils must be HyperSoft® 3D or HyperSoft® Helical coils. Phase 2: Frame with MicroVention HydroFrame® or HydroSoft® 3D coils and fill/finish with sufficient hydrogel coils to ensure 50% hydrogel by length. The intent to treat is to frame, fill and finish with all hydrogel coils. However, at the discretion of the treating physician, a bare platinum coil may be used to fill or finish, as long as a minimum of 50% (in total coil length) of hydrogel coils are used.
5. Signed informed consent.
Exclusion Criteria
Candidates will be ineligible for enrollment in the Study if any of the following conditions apply:
1. Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the current Study inclusion criteria (i.e. if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the Study). Non-treated additional aneurysms may be treated after 30 days from the incident procedure with any coil type that the operator chooses, and, if eligible, those aneurysms may also be enrolled as an additional enrollment.
2. Prior treatment (surgical or endovascular) of the target aneurysm
3. Subject with social, medical, or psychological conditions that interfere with treatment and follow-up evaluation
4. Women who are pregnant or plan to become pregnant during the Study
5. Use of other modified coils (Matrix, HydroCoil® or fibered coils) - except Phase 2 as noted above in the inclusion criteria
6. Use (current or prior) of liquid embolic material in the treatment of the target aneurysm
7. Life expectancy less than 12 months
8. Presence of arteriovenous malformation or fistula
9. Presence of fusiform, mycotic, traumatic, dissecting or tumoral aneurysms in any location 10. Intended or planned aneurysm treatment by parent vessel occlusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02259504
Study Brief:
Protocol Section:
NCT02259504