Intracranial AneurysmsVOLCANNCT01754051
A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
An observational study of Intracranial Aneurysms, run by Penumbra Inc. at 1 site in France.
Trial summary
This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- PC 400 coils
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to 3 Oct 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 200 patients with intracranial aneurysms treated by the PC 400 System at up to 20 centers will be enrolled.
Who may be able to join
- Patients older than 18 years
- Intracranial aneurysms >2mm, ruptured or unruptured
Who cannot join
- Fusiform aneurysms
- Dissecting aneurysms
- Aneurysms associated with brain AVMs
- Multiple aneurysms
- Re-treated aneurysms
- Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.
- Conditions
- Intracranial Aneurysms
- Being tested
- PC 400 coils
- 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 coilsDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment by the PC 400 coils | Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System in the Instructions for Use. Receives: Device: PC 400 coils |
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
Measured: During the procedure
Time of fluoroscopic exposure
Measured: During the procedure
Procedural device-related serious adverse events at immediate post-procedure
Measured: During the procedure
Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale
Measured: At 1 year post-procedure
Secondary outcomes (2)
Acute occlusion of the aneurysm sac at immediate post-procedure
Measured: At immediate post-procedure
Adverse events occurring during the procedure and in the 30±7 days following the treatment.
Measured: During and at 30 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 posted21 Dec 2012 (estimated)
- Study startJan 2013
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Jérôme Berge, MD, Principal investigator, CHU Pellegrin - Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754051
- Sponsor's protocol ID
- CLP 4818
- Other IDs
- CLP 4818
- Acronym
- VOLCAN
- Status last verified
- May 2018
- First submitted
- 17 Dec 2012
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
- ClinicalTrials.gov ID
- NCT01754051
- Acronym / sponsor ID
- VOLCAN / CLP 4818
- Conditions
- Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment by the PC 400 coils | – | Device: PC 400 coilsPatients enrolled in this study must be those treated according to the cleared indication for the PC 400 System in the Instructions for Use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 200 patients with intracranial aneurysms treated by the PC 400 System at up to 20 centers will be enrolled.
Key inclusion criteria (2 listed)
- Patients older than 18 years
- Intracranial aneurysms >2mm, ruptured or unruptured
Key exclusion criteria (6 listed)
- Fusiform aneurysms
- Dissecting aneurysms
- Aneurysms associated with brain AVMs
- Multiple aneurysms
- Re-treated aneurysms
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 | Device | Treatment by the PC 400 coils |
Primary outcome
Packing density with the number of coils implanted
Time frame: During the procedure
Time of fluoroscopic exposure
Time frame: During the procedure
Procedural device-related serious adverse events at immediate post-procedure
Time frame: During the procedure
Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale
Time frame: At 1 year post-procedure
2 secondary outcomes
Acute occlusion of the aneurysm sac at immediate post-procedure
Time frame: At immediate post-procedure
Adverse events occurring during the procedure and in the 30±7 days following the treatment.
Time frame: During and at 30 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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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.
Dr. Jérôme Berge, MD principal investigator
CHU Pellegrin - Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by Penumbra Inc. at 1 site in France.
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 2 inclusion and 6 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: During the procedure). The study lists 4 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 17 May 2018.