Complete Occlusion of Coilable Aneurysms

NCT ID: NCT00777907

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2015-04-30

Brief Summary

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

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Coil embolization

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

Group Type: ACTIVE_COMPARATOR

Coil embolization

Intervention Type: DEVICE

Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.

Pipeline

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

Group Type: EXPERIMENTAL

Pipeline Embolization Device (PED)

Intervention Type: DEVICE

1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.

Interventions

Pipeline Embolization Device (PED)

1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.

Intervention Type: DEVICE

Coil embolization

Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.

Intervention Type: DEVICE

Other Intervention Names

Pipeline Embolization Device, PED

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chestnut Medical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Fiorella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurologic Institute

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

SUNY Stony Brook

Stony Brook, New York, United States

Countries

United States

Other Identifiers

CLP-0004

Identifier Type: -

Identifier Source: org_study_id