COCOA: Complete Occlusion of Coilable Aneurysms
Study Details
Study Description
Brief Summary
To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Coil embolization Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed. Stents are not allowed in this arm. |
Device: Coil embolization
Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.
|
| Experimental: Pipeline Placement of 1 or more Pipeline Embolization Device(s)(PED) into the parent artery at the target aneurysm. |
Device: Pipeline Embolization Device (PED)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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. [180 days]
Secondary Outcome Measures
- Rate of complete target aneurysm occlusion [1, 3 and 5 years]
- Incidence of ipsilateral major stroke [180 days]
- Change in modified Rankin scale (MRS) [180 days, 1, 3 and 5 years]
- Incidence of device-related adverse events [180 days, 1, 3 and 5 years]
- Change from baseline in neurologic signs or symptoms related to the target aneurysm [180 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 21 to 75 years, inclusive
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Patient has a single target IA that:
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is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
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is saccular
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has a parent vessel with diameter 2.5-5.0 mm
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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
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Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
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** Adjunctive techniques include intravascular balloons ["balloon remodeling"], 3D coils, dual catheter techniques.
Exclusion Criteria:
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Target IA has BOTH neck >4 mm AND size (maximum fundus diameter) >10 mm
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More than one IA requires treatment in the next 6 months
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Subarachnoid hemorrhage in the past 60 days
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Any intracranial hemorrhage in the last 42 days
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Major surgery in the last 42 days
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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)
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Known irreversible bleeding disorder
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Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
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Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
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Prior stent placement at target site
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Contraindication to CT scan AND MRI
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Known allergy to contrast used in angiography that cannot be medically controlled
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Known severe allergy to platinum or cobalt/chromium alloys
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Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
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Woman of child-bearing potential who cannot provide a negative pregnancy test
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Evidence of active infection at the time of treatment
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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)
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Current use of cocaine or other illicit substance
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Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
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Extracranial stenosis greater than 50% in the carotid artery
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Intracranial stenosis greater than 50% in the treated vessel
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barrow Neurological Institute | Phoenix | Arizona | United States | 85013 |
| 2 | SUNY Stony Brook | Stony Brook | New York | United States | 11794 |
Sponsors and Collaborators
- Chestnut Medical Technologies
Investigators
- Principal Investigator: David Fiorella, MD, PhD, Barrow Neurologic Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLP-0004