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Complete Occlusion of Coilable Aneurysms (COCOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00777907
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):

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
Intracranial Aneurysm Device: Pipeline Embolization Device (PED) Device: Coil embolization Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complete Occlusion of Coilable Aneurysms
Study Start Date : October 2008
Primary Completion Date : November 2014
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Pipeline Embolization Device, PED


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Rate of complete target aneurysm occlusion [ Time Frame: 1, 3 and 5 years ]
  2. Incidence of ipsilateral major stroke [ Time Frame: 180 days ]
  3. Change in modified Rankin scale (MRS) [ Time Frame: 180 days, 1, 3 and 5 years ]
  4. Incidence of device-related adverse events [ Time Frame: 180 days, 1, 3 and 5 years ]
  5. Change from baseline in neurologic signs or symptoms related to the target aneurysm [ Time Frame: 180 days ]

Eligibility Criteria

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 to 75 years, inclusive
  • Patient has a single target IA that:

    1. is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
    2. is saccular
    3. 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)
  • 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.

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777907


Locations
United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, New York
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
More Information

Responsible Party: Chestnut Medical Technologies
ClinicalTrials.gov Identifier: NCT00777907     History of Changes
Other Study ID Numbers: CLP-0004
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Chestnut Medical Technologies:
neurovascular embolization
therapeutic embolization

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases