Intracranial AneurysmsACENCT01465841
Study of the Penumbra Coil 400 System to Treat Aneurysm
A study testing PC 400 coils (Penumbra ) in people with Intracranial Aneurysms and Peripheral Aneurysms, run by Penumbra Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysms, Peripheral Aneurysms
- What is being tested?
- PC 400 coils (Penumbra )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2011to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rush University Medical Center
Chicago, Illinois, 60612-3833
The Methodist Hospital Research Institute
Houston, Texas, 77030
Fort Sanders Medical Center
Knoxville, Tennessee, 37916
Mount Sinai School of Medicine
New York, New York, NY 10029
Hoag Hospital
Newport Beach, California, 92658-6100
State University of New York Upstate Medical Center
Syracuse, New York, 13210
About this study
Official title: 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.
- Conditions
- Intracranial Aneurysms, Peripheral Aneurysms
- Being tested
- PC 400 coils (Penumbra )
- Keywords
- intracranial aneurysms, Peripheral aneurysms, acute treatment, PC 400 System, packing density
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC 400 coils (Penumbra )Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Embolization with the PC 400 coils | Experimental | Not described Receives: Device: PC 400 coils (Penumbra ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At immediate post-procedure
Secondary outcomes (2)
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.
Measured: At immediate post-procedure
Intracranial Hemorrhage
Measured: At discharge or 3 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siu P Sit, PhD, Study director, Penumbra Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465841
- Sponsor's protocol ID
- CLP 4492
- Other IDs
- CLP 4492
- Acronym
- ACE
- Status last verified
- Jun 2020
- First submitted
- 28 Oct 2011
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
- ClinicalTrials.gov ID
- NCT01465841
- Acronym / sponsor ID
- ACE / CLP 4492
- Conditions
- Intracranial Aneurysms, Peripheral Aneurysms
- Keywords
- intracranial aneurysms, Peripheral aneurysms, acute treatment, PC 400 System, packing density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization with the PC 400 coils | Experimental | Device: PC 400 coils (Penumbra ) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Embolization with the PC 400 coils |
Primary outcome
Packing Density With the Number of Coils Implanted
Time frame: At immediate post-procedure
The data will be captured at the end of the coiling procedure which is standard for aneurysm studies.
Time of Fluoroscopic Exposure
Time frame: At immediate post-procedure
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
Time frame: At immediate post-procedure
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.
2 secondary outcomes
Acute Occlusion of the Aneurysm Sac
Time frame: At immediate post-procedure
Intracranial Hemorrhage
Time frame: At discharge or 3 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siu P Sit, PhD study director
Penumbra Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC 400 coils (Penumbra ) in people with Intracranial Aneurysms and Peripheral Aneurysms, run by Penumbra Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Packing Density With the Number of Coils Implanted (time frame: At immediate post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.