Study of the Penumbra Coil 400 System to Treat Aneurysm

Penumbra Inc.517 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

517

Conditions

Intracranial Aneurysms Peripheral Aneurysms

Interventions

The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (6)

Hoag Hospital

Newport Beach, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Mount Sinai School of Medicine

New York, New York, United States

State University of New York Upstate Medical Center

Syracuse, New York, United States

Fort Sanders Medical Center

Knoxville, Tennessee, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: At immediate post-procedure

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.

Time frame: At immediate post-procedure

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.

Time frame: At immediate post-procedure

Secondary Outcomes

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.

Time frame: At immediate post-procedure

Intracranial Hemorrhage

Time frame: At discharge or 3 days post-procedure