Intracranial AneurysmsCARENCT02122133
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
An observational study of Intracranial Aneurysms, run by Penumbra Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- PC 400
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 19 Oct 2016
- How long will I take part?
- 3 Days
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.
Who may be able to join
- Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms.
- Patients treated with conventional coils should be treated per their IFU.
- Adjunctive use of stents, balloons or liquid embolics, if considered appropriate by investigators, is allowed.
Who cannot join
- Pre-planned use of multiple coil systems and/or flow diverters.
Trial locations and contacts
1 site in 1 country.
United States1 site
Overlake Hospital Medical Center
Bellevue, Washington, 98004
About this study
Official title: CARE: A Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.
- Conditions
- Intracranial Aneurysms
- Being tested
- PC 400
- Keywords
- IC aneurysms, coil embolization, PC 400, radiation exposure,
- 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 400Device
| Study group | Role | What they receive |
|---|---|---|
| PC 400 | Patients treated with the PC 400 according to the IFU Receives: Device: PC 400 | |
| Conventional Embolic Coils | These are any approved embolic coils on the market used as part of the standard of care for treating intracranial aneurysms. Receives: Device: PC 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].
Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time.
Measured: At immediate post-procedure
2. Procedural serious adverse events
Measured: Procedural serious adverse events up until 3 days or discharge, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startMay 2015
- Primary completion19 Oct 2016
- Study completion19 Oct 2016
Why it stopped: Business decision to focus on other studies. No safety concern.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abhineet Chowdhary, MD, Principal investigator, Director of Neuro-Interventional Surgery, Overlake Hospital Medical Center, Bellevue, WA 98004
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122133
- Sponsor's protocol ID
- CLP 7495
- Acronym
- CARE
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2014
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARE: A Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
- ClinicalTrials.gov ID
- NCT02122133
- Acronym / sponsor ID
- CARE / CLP 7495
- Conditions
- Intracranial Aneurysms
- Keywords
- IC aneurysms, coil embolization, PC 400, radiation exposure,
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision to focus on other studies. No safety concern.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- 19 Oct 2016 (actual)
- Study completion
- 19 Oct 2016 (actual)
- First posted
- 24 Apr 2014 (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.
The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PC 400 | – | Device: PC 400Patients treated with the PC 400 according to the IFU |
| Conventional Embolic Coils | – | Device: PC 400These are any approved embolic coils on the market used as part of the standard of care for treating intracranial aneurysms. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.
Key inclusion criteria (3 listed)
- Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms.
- Patients treated with conventional coils should be treated per their IFU.
- Adjunctive use of stents, balloons or liquid embolics, if considered appropriate by investigators, is allowed.
Key exclusion criteria (1 listed)
- Pre-planned use of multiple coil systems and/or flow diverters.
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 | Device | Conventional Embolic Coils, PC 400 |
Primary outcome
1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].
Time frame: At immediate post-procedure
Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time.
2. Procedural serious adverse events
Time frame: Procedural serious adverse events up until 3 days or discharge, whichever occurs first.
Results and safety
The study was stopped early (reason given: Business decision to focus on other studies. No safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
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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.
Abhineet Chowdhary, MD principal investigator
Director of Neuro-Interventional Surgery, Overlake Hospital Medical Center, Bellevue, WA 98004
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 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 3 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: stopped early, as of the sponsor's last update on 12 Apr 2019. 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 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?
The study was stopped early (reason given: Business decision to focus on other studies. No safety concern.). Results are not available in the source record.
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?
1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time]. (time frame: At immediate post-procedure). The study lists 2 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 12 Apr 2019.