Complete Occlusion of Coilable Aneurysms (COCOA)

To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Coil embolization; Device: Pipeline Embolization Device (PED)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • New York
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Pipeline Embolization Device, PED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chestnut Medical Technologies
• Investigators: Principal Investigator: David Fiorella, MD, PhD, Barrow Neurologic Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 20, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (Estimate): October 22, 2008

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: therapeutic embolization; neurovascular embolization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CLP-0004