Using i-ED coils to treat cerebral aneurysms
Kaneka Endovascular Embolization and Protection
NA · Kaneka Medical America LLC · NCT05563051
This study is testing how well a new type of coil works to treat brain aneurysms in patients and whether it is safe over time.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kaneka Medical America LLC (industry) |
| Locations | 4 sites (Grand Blanc, Michigan and 3 other locations) |
| Trial ID | NCT05563051 on ClinicalTrials.gov |
What this trial studies
This study aims to gather real-world clinical data on the performance of i-ED coils for treating intracranial aneurysms. It is a prospective, multi-center, non-randomized registry that will enroll up to 164 patients, who will be followed for 180 days and again at 365 days post-procedure. The study will assess both the acute and long-term outcomes of using i-ED coils, which may be utilized alone or in conjunction with other devices. The goal is to characterize the effectiveness and safety of this embolization technique.
Who should consider this trial
Good fit: Ideal candidates include individuals with a target aneurysm size between 4mm and 14mm, whether ruptured or unruptured, who are suitable for coil embolization.
Not a fit: Patients with unstable neurological deficits, high mRS scores, or evidence of active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with cerebral aneurysms.
How similar studies have performed: Other studies have explored similar embolization techniques, but the specific use of i-ED coils in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Target aneurysm of 4mm - 14mm in size * Ruptured or unruptured * Suitable for embolization with coils * May be treated with or without assist devices Exclusion Criteria: * Unstable neurological deficit in unruptured cases (condition worsening within last 90 days) * Pre-planned staged procedure of target aneurysm * mRS score 3 or more * Hunt Hess Score more than 3 for subjects with ruptured aneurysm * Evidence of active infection (e.g.,fever, temperature \>38 degrees C and/or WBC \>15,000)
Where this trial is running
Grand Blanc, Michigan and 3 other locations
- McLaren Health Care — Grand Blanc, Michigan, United States (RECRUITING)
- Northwell Health Lenox Hill Hospital — New York, New York, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- SSM Health St. Anthony's Hospital — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Ajit Puri, MD — University of Massachusetts, Worcester
- Study coordinator: Yuki Arimoto
- Email: yuki.arimoto@kaneka.com
- Phone: 3475253625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aneurysm Cerebral, aneurysm, coil, i-ED COIL, embolization, neuro endovascular