Complete Occlusion of Coilable Aneurysms (COCOA)

Chestnut Medical Technologies

Status and phase: Completed; Phase 3

Conditions: Intracranial Aneurysm

Treatments: Device: Pipeline Embolization Device (PED); Device: Coil embolization

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777907

CLP-0004

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Coil embolization

Active Comparator group

Description:

Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed. Stents are not allowed in this arm.

Treatment:

Device: Coil embolization

Pipeline

Experimental group

Description:

Placement of 1 or more Pipeline Embolization Device(s)(PED) into the parent artery at the target aneurysm.

Treatment:

Device: Pipeline Embolization Device (PED)