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

Primary Purpose

Intracranial Aneurysms, Peripheral Aneurysms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PC 400 coils (Penumbra )
Sponsored by
Penumbra Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysms focused on measuring intracranial aneurysms, Peripheral aneurysms, acute treatment, PC 400 System, packing density

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hoag Hospital
  • Rush University Medical Center
  • Mount Sinai School of Medicine
  • State University of New York Upstate Medical Center
  • Fort Sanders Medical Center
  • The Methodist Hospital Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embolization with the PC 400 coils

Arm Description

Outcomes

Primary Outcome Measures

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 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.
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.

Secondary Outcome Measures

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.
Intracranial Hemorrhage

Full Information

First Posted
October 28, 2011
Last Updated
June 18, 2020
Sponsor
Penumbra Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01465841
Brief Title
Study of the Penumbra Coil 400 System to Treat Aneurysm
Acronym
ACE
Official Title
ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms, Peripheral Aneurysms
Keywords
intracranial aneurysms, Peripheral aneurysms, acute treatment, PC 400 System, packing density

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
517 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Embolization with the PC 400 coils
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PC 400 coils (Penumbra )
Intervention Description
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.
Primary Outcome Measure Information:
Title
Packing Density With the Number of Coils Implanted
Description
The data will be captured at the end of the coiling procedure which is standard for aneurysm studies.
Time Frame
At immediate post-procedure
Title
Time of Fluoroscopic Exposure
Description
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
Title
Procedural Device-related Serious Adverse Events
Description
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 Outcome Measure Information:
Title
Acute Occlusion of the Aneurysm Sac
Description
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
Title
Intracranial Hemorrhage
Time Frame
At discharge or 3 days post-procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siu P Sit, PhD
Organizational Affiliation
Penumbra Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658-6100
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3833
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
NY 10029
Country
United States
Facility Name
State University of New York Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Fort Sanders Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of the Penumbra Coil 400 System to Treat Aneurysm

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