Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneu… (NCT05636124) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
United States50 participantsStarted 2023-06-02
Plain-language summary
This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team
* Wide neck side wall or bifurcation intracranial aneurysms (neck \> or = to 4 mm or dome-to-neck ratio \< 2) within the anterior or posterior circulation
* The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling)
* Patients are 18-80 years of age (inclusive)
* Patient must be Hunt and Hess grade 0 to 3
* Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney.
* Aneurysm 6-14 mm in diameter
* Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment
* The patient has not been previously enrolled in this trial or another related ongoing trial
* The aneurysm has not been previously treated by coiling or clipping
Exclusion criteria:
* Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the Kaneka 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 c…
What they're measuring
1
Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment