Complete Occlusion of Coilable Aneurysms (COCOA)

• ClinicalTrials.gov Identifier: NCT00777907
• Recruitment Status: Completed
• First Posted: October 22, 2008
• Last Update Posted: August 7, 2015
• Sponsor: Chestnut Medical Technologies
• Information provided by (Responsible Party): Chestnut Medical Technologies

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
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: April 2015

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

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: CLP-0004
• First Posted: October 22, 2008
• Last Update Posted: August 7, 2015
• Last Verified: August 2015

Keywords provided by Chestnut Medical Technologies:

neurovascular embolization; therapeutic embolization

Additional relevant MeSH terms:

Intracranial Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases