NCT00777907

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

6.1 years

First QC Date

October 20, 2008

Last Update Submit

August 5, 2015

Conditions

Intracranial Aneurysm

Keywords

neurovascular embolizationtherapeutic embolization

Outcome Measures

Primary Outcomes (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.

    180 days

Secondary Outcomes (5)

  • 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

Study Arms (2)

Coil embolization

ACTIVE COMPARATOR

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

Device: Coil embolization

Pipeline

EXPERIMENTAL

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

Device: Pipeline Embolization Device (PED)

Interventions

Pipeline Embolization Device (PED)DEVICE

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

Also known as: Pipeline Embolization Device, PED
Pipeline
Coil embolizationDEVICE

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

Coil embolization

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 to 75 years, inclusive
  • Patient has a single target IA that:
  • is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
  • is saccular
  • 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.

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

SUNY Stony Brook

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • David Fiorella, MD, PhD

    Barrow Neurologic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 22, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2014

Study Completion

April 1, 2015

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

US(2)