Intracranial AneurysmPhase 3COCOANCT00777907
Complete Occlusion of Coilable Aneurysms
A Phase 3 study testing Pipeline Embolization Device (PED) and Coil embolization in people with Intracranial Aneurysm, run by Chestnut Medical Technologies at 2 sites in United States.
Trial summary
To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Pipeline Embolization Device (PED) and Coil embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Apr 2015
- Phase
- Phase 3
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 75 years, inclusive
- Patient has a single target IA that:
- is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
- is saccular
- has a parent vessel with diameter 2.5-5.0 mm
- If target IA has a neck >4 mm, at least 2 of 3 members of an independent expert committee (IEC) have confirmed that coil embolization with optional adjunctive techniques** has a very high likelihood of procedural success (i.e., coil placement and retention)
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- Subject has provided written informed consent using the IRB-approved consent form
- Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
- ** Adjunctive techniques include intravascular balloons ["balloon remodeling"], 3D coils, dual catheter techniques.
Who cannot join
- Target IA has BOTH neck >4 mm AND size (maximum fundus diameter) >10 mm
- More than one IA requires treatment in the next 6 months
- Subarachnoid hemorrhage in the past 60 days
- Any intracranial hemorrhage in the last 42 days
- Major surgery in the last 42 days
- Coils in place in the target IA
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- Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
- Known irreversible bleeding disorder
- Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
- Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
- Prior stent placement at target site
- Contraindication to CT scan AND MRI
- Known allergy to contrast used in angiography that cannot be medically controlled
- Known severe allergy to platinum or cobalt/chromium alloys
- Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
- Woman of child-bearing potential who cannot provide a negative pregnancy test
- Evidence of active infection at the time of treatment
- Other known conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
- Current use of cocaine or other illicit substance
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
- Extracranial stenosis greater than 50% in the carotid artery
- Intracranial stenosis greater than 50% in the treated vessel
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barrow Neurological Institute
Phoenix, Arizona, 85013
SUNY Stony Brook
Stony Brook, New York, 11794
About this study
To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms
- Conditions
- Intracranial Aneurysm
- Being tested
- Pipeline Embolization Device (PED), Coil embolization
- Keywords
- neurovascular embolization, therapeutic embolization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipeline Embolization Device (PED)Device
Also called Pipeline Embolization Device, PED
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.
Coil embolizationDevice
Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.
| Study group | Role | What they receive |
|---|---|---|
| Coil embolization | Active comparator | Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed. Stents are not allowed in this arm. Receives: Device: Coil embolization |
| Pipeline | Experimental | Placement of 1 or more Pipeline Embolization Device(s)(PED) into the parent artery at the target aneurysm. Receives: Device: Pipeline Embolization Device (PED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death.
Measured: 180 days
Secondary outcomes (5)
Rate of complete target aneurysm occlusion
Measured: 1, 3 and 5 years
Incidence of ipsilateral major stroke
Measured: 180 days
Change in modified Rankin scale (MRS)
Measured: 180 days, 1, 3 and 5 years
Incidence of device-related adverse events
Measured: 180 days, 1, 3 and 5 years
Change from baseline in neurologic signs or symptoms related to the target aneurysm
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fiorella, MD, PhD, Principal investigator, Barrow Neurologic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777907
- Sponsor's protocol ID
- CLP-0004
- Acronym
- COCOA
- Status last verified
- Aug 2015
- First submitted
- 20 Oct 2008
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Occlusion of Coilable Aneurysms
- ClinicalTrials.gov ID
- NCT00777907
- Acronym / sponsor ID
- COCOA / CLP-0004
- Conditions
- Intracranial Aneurysm
- Keywords
- neurovascular embolization, therapeutic embolization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chestnut Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Oct 2008 (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.
To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coil embolization | Active comparator | Device: Coil embolizationPlacement of bare platinum coils into the target aneurysm with balloon remodeling allowed. Stents are not allowed in this arm. |
| Pipeline | Experimental | Device: Pipeline Embolization Device (PED)Placement of 1 or more Pipeline Embolization Device(s)(PED) into the parent artery at the target aneurysm. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 21 to 75 years, inclusive
- Patient has a single target IA that:
- If target IA has a neck >4 mm, at least 2 of 3 members of an independent expert committee (IEC) have confirmed that coil embolization with optional adjunctive techniques** has a very high likelihood of procedural success (i.e., coil placement and retention)
- Subject has provided written informed consent using the IRB-approved consent form
- Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
Key exclusion criteria (22 listed)
- Target IA has BOTH neck >4 mm AND size (maximum fundus diameter) >10 mm
- More than one IA requires treatment in the next 6 months
- Subarachnoid hemorrhage in the past 60 days
- Any intracranial hemorrhage in the last 42 days
- Major surgery in the last 42 days
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 |
|---|---|---|
| Pipeline Embolization Device (PED)Also: Pipeline Embolization Device, PED1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach. | Device | Pipeline |
| Coil embolizationPlacement of bare platinum coils into the target aneurysm with balloon remodeling allowed. | Device | Coil embolization |
Primary outcome
Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death.
Time frame: 180 days
5 secondary outcomes
Rate of complete target aneurysm occlusion
Time frame: 1, 3 and 5 years
Incidence of ipsilateral major stroke
Time frame: 180 days
Change in modified Rankin scale (MRS)
Time frame: 180 days, 1, 3 and 5 years
Incidence of device-related adverse events
Time frame: 180 days, 1, 3 and 5 years
Change from baseline in neurologic signs or symptoms related to the target aneurysm
Time frame: 180 days
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 7 Aug 2015.
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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.
David Fiorella, MD, PhD principal investigator
Barrow Neurologic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pipeline Embolization Device (PED) and Coil embolization in people with Intracranial Aneurysm, run by Chestnut Medical Technologies at 2 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 9 inclusion and 22 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death. (time frame: 180 days). 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 Aug 2015.