Kaneka Endovascular Embolization and Protection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

NCT01702584

Stent Embolisation

UNKNOWN

Reduction in Volume and Prolonged Shrinkage of Brain Aneurysms After Combined Endovascular Interventions

NCT06541275

Brain Aneurysm

ENROLLING_BY_INVITATION

Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy

NCT07214623

Chronic Subdural Hematoma cSDH Chronic Subdural Hematomas

NOT_YET_RECRUITING

Registry of Emergent Large VeSsel OCclUsion DuE to IntraCranial AtherosclerosiS

NCT05403593

Intracranial Stenosis Large Vessel Occlusion Mechanical Thrombectomy

COMPLETED

Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window

NCT04256096

Stroke, Ischemic

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)

Study Duration

Anticipated timeline for study:

Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aneurysm Cerebral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional treatment

Open label

Group Type OTHER

i-ED COIL

Intervention Type DEVICE

The i-ED COIL System (i-ED COIL and detachment box) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

i-ED COIL

The i-ED COIL System (i-ED COIL and detachment box) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Embolic coils Embolization coils

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No