Intracranial Aneurysms Clinical Trial
— ACEOfficial title:
ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
Verified date | June 2020 |
Source | Penumbra Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.
Status | Completed |
Enrollment | 517 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System which is for the endovascular embolization of: - Intracranial aneurysms - Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae - Arterial and venous embolizations in the peripheral vasculature Exclusion Criteria: - Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable. |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
United States | The Methodist Hospital Research Institute | Houston | Texas |
United States | Fort Sanders Medical Center | Knoxville | Tennessee |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Hoag Hospital | Newport Beach | California |
United States | State University of New York Upstate Medical Center | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
Penumbra Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Packing Density With the Number of Coils Implanted | The data will be captured at the end of the coiling procedure which is standard for aneurysm studies. | At immediate post-procedure | |
Primary | Time of Fluoroscopic Exposure | The total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coiling procedure. | At immediate post-procedure | |
Primary | Procedural Device-related Serious Adverse Events | Procedural on-the-table serious adverse events will be captured and recorded at the end of the procedure. The duration of the procedure can be variable, depending on the time to access the target lesion and the time to complete the coiling procedure. | At immediate post-procedure | |
Secondary | Acute Occlusion of the Aneurysm Sac | Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome. | At immediate post-procedure | |
Secondary | Intracranial Hemorrhage | At discharge or 3 days post-procedure |
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