Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE)

ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System

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 Overview

• Status: Completed
• Conditions: Intracranial Aneurysms; Peripheral Aneurysms
• Intervention / Treatment: Device: PC 400 coils (Penumbra )

• Study Type: Interventional
• Enrollment (Actual): 517
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92658-6100
      • Hoag Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612-3833
      • Rush University Medical Center
  • New York
    • New York, New York, United States, NY 10029
      • Mount Sinai School of Medicine
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Embolization with the PC 400 coils

Device: PC 400 coils (Penumbra ); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Intracranial Hemorrhage		At discharge or 3 days post-procedure

Collaborators and Investigators

• Sponsor: Penumbra Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: November 3, 2011
• First Posted (Estimate): November 6, 2011

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: intracranial aneurysms; acute treatment; Peripheral aneurysms; PC 400 System; packing density
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CLP 4492 (Other Identifier: Penumbra Inc)